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MedWatch Safety Alerts RSS Feed
  • UPDATE: Increased Rate of Mortality in Patients Receiving Abiomed Impella RP System - Letter to Health Care Providers

    The FDA is providing the most recent, interim post-approval study results for Abiomed's Impella RP System. [ Read more ]
  • B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Twenty-Two (22) Lots of Blood Administration Sets, Due to Potential for Leakage at the Joint Between the Blood Filters and Tubing

    B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets. [ Read more ]
  • Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

    Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below. Ranitidine Tablets, USP, 150 mg and 300 mg [ Read more ]
  • Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps - Letter to Health Care Providers

    The FDA is evaluating recent reports of Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices shutting down while running on battery power. [ Read more ]
  • Precision Dose Inc. Issues Voluntary Nationwide Recall of Ranitidine Oral Solution, USP 150 mg/10 mL Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

    Precision Dose Inc. is voluntarily recalling 5 lots of Ranitidine Oral Solution, USP 150 mg/10 mL to the consumer level. Ranitidine Oral Solution, USP 150 mg/10 mL, is being recalled because of potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. [ Read more ]
  • Update On Device Failure Associated with Getinge's Maquet/Datascope Intra-Aortic Balloon Pumps – Letter to Health Care Providers

    The U.S. Food and Drug Administration (FDA) is providing an update on our evaluation of device failures associated with Getinge's Maquet/Datascope intra-aortic balloon pump (IABP) devices: Cardiosave (Hybrid and Rescue), CS300 and CS100/CS100i. [ Read more ]
  • Medtronic Recalls Remote Controllers for MiniMed Insulin Pumps for Potential Cybersecurity Risks

    The remote controllers of some Medtronic MiniMed insulin pumps are vulnerable to cybersecurity risks. Unauthorized persons could record and replay the wireless communication from the remote to the MiniMed insulin pump leading to the administration of one ore more unintended boluses of insulin. [ Read more ]
  • Philips Medical Systems (Cleveland) Recalls Forte Gamma Camera System Due to Potential for the Detector to Drop

    The detector on the Forte Gamma Camera System has the potential to drop without warning which could result in a serious injury or death. [ Read more ]
  • Zimmer Biomet Recalls ROSA Brain 3.0 Robotic Surgery System Due to Software Issue that Incorrectly Positions the Robotic Arm

    Zimmer Biomet recalled the ROSA Brain Device due to a software issue which can drive the robotic arm to an incorrect position resulting in risks for the patient. [ Read more ]
  • 2019 Medical Device Recalls

    The list below contains recalls that were issued in 2019. [ Read more ]
  • Golden State Medical Supply, Inc. Issues a Voluntary Nationwide Recall of Ranitidine Hydrochloride 150mg and 300mg Capsules (Manufactured by Novitium Pharma LLC) Due to an Elevated Amount of Unexpected Impurity, N-Nitrosodimethylamine (NDMA)

    Golden State Medical Supply, Incorporated (GSMS, Inc) based upon a manufacturer’s recall by Novitium Pharma LLC (Novitium), is voluntarily instituting a recall of all quantities and lots, within expiry, of Ranitidine HCl 150mg and 300mg Capsules to the consumer level because of potential presence of [ Read more ]
  • Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules Due to an Undeclared PDE-5 Inhibitor Found in the Product

    Nature’s Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 Male Enhancement Capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor. [ Read more ]
  • Med Man Issues Voluntary Nationwide Recall of Up2 Due to Presence of Undeclared Sildenafil

    Med Man Distribution is voluntarily recalling all lots of Up2 Dietary supplement There is no other all-natural libido for men and women to the consumer level. [ Read more ]
  • American Health Packaging Issues Voluntary Nationwide Recall of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups Due to the Detection of N-nitrosodimethylamine (NDMA) Impurity

    American Health Packaging is voluntarily recalling eight lots of Ranitidine Syrup (Ranitidine Oral Solution USP) 150 mg/10 mL Liquid Unit Dose Cups to the consumer level due to the detection of trace amounts of an unexpected impurity found in the finished drug product. The impurity detected in the f [ Read more ]
  • Abbott Recalls CentriMag Circulatory Support System Motor Due to Pump and Motor Issues

    Abbott is recalling their CentriMag System due to a calibration system error resulting from electromagnetic interference (EMI) that may cause low or no flow from the device, the console screen to blank, and various inaccurate alarms. [ Read more ]
FDA Press Releases RSS Feed
  • FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk

    FDA sends warning to companies for offering unapproved umbilical cord blood products that may put patients at risk [ Read more ]
  • Statement from Janet Woodcock, M.D., director of FDA’s Center for Drug Evaluation and Research, on impurities found in diabetes drugs outside the U.S.

    The FDA is investigating whether metformin in the U.S. market contains NDMA, and whether it is above the acceptable daily intake limit of 96 nanograms. [ Read more ]
  • FDA approves first generics of Gilenya

    The U.S. Food and Drug Administration today approved three applications for first generics of Gilenya (fingolimod) capsules for the treatment of relapsing forms of multiple sclerosis (MS) in adult patients [ Read more ]
  • FDA authorizes marketing of diagnostic test that uses novel technology to detect MRSA bacteria

    Today, the U.S. Food and Drug Administration authorized marketing of a new diagnostic test based on bacterial viability and novel technology to detect Methicillin-resistant Staphylococcus aureus (MRSA) bacterial colonization, a widespread cause of hospital-acquired infections. The cobas vivoDx MRSA [ Read more ]
  • FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases

    FDA launches app for health care professionals to report novel uses of existing medicines for patients with difficult-to-treat infectious diseases [ Read more ]
  • FDA approves novel treatment to target abnormality in sickle cell disease

    FDA granted accelerated approval to Oxbryta (voxelotor) for the treatment of sickle cell disease in adults and pediatric patients 12 years of age and older [ Read more ]
  • FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health

    FDA orders Puerto Rico fertility clinic to cease manufacturing immediately for significant violations that pose a danger to health [ Read more ]
  • Statement on efforts to help make development of biosimilar and interchangeable insulin products more efficient

    FDA issues guidance to help make development of biosimilar and interchangeable insulin products more efficient. [ Read more ]
  • California-based food manufacturer agrees to stop production after repeated food safety violations

    California-based food manufacturer agrees to stop production after repeated food safety violations [ Read more ]
  • Statement on new steps to advance innovation in medical device sterilization with ethylene oxide

    FDA is announcing the next steps in our ongoing efforts in medical device sterilization with ethylene oxide. This includes the selection results of our new Innovation Challenges, a recap and action items from our recent public advisory committee meeting, and the announcement of a new pilot program. [ Read more ]
  • Statement by FDA Commissioner Scott Gottlieb, M.D., and Biologics Center Director Peter Marks, M.D., Ph.D. on FDA’s continued efforts to stop stem cell clinics and manufacturers from marketing unapproved products that put patients at risk

    FDA statement on stem cell enforcement actions and agency activities to facilitate legitimate product development [ Read more ]
  • FDA approves system for the delivery of ear tubes under local anesthesia to treat ear infection

    FDA has approved a new system, the Tubes Under Local Anesthesia (Tula) System, for the delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be inserted into the eardrum to treat recurrent ear infections. [ Read more ]
  • FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns

    FDA warns 15 companies for illegally selling various products containing cannabidiol as agency details safety concerns [ Read more ]
  • FDA approves new treatment for adults with partial-onset seizures

    Today, the FDA approved a new treatment for adults with partial-onset seizures [ Read more ]
  • FDA takes second action under international collaboration, approves new treatment option for patients with chronic lymphocytic leukemia

    As part of Project Orbis, a collaboration with the Australian Therapeutic Goods Administration and Health Canada, the FDA granted supplemental approval to Calquence (acalabrutinib) for the treatment of adults with chronic lymphocytic leukemia or small lymphocytic lymphoma [ Read more ]
Food and Drugs Administration--Recalls/Safety Alerts
  • Tailor Cut Produce Recalls Cut Fruit Mix Because of Possible Health Risk

    Tailor Cut Produce of New Jersey, is recalling its Fruit luau, cut honeydew, cut cantaloupe and cut pineapple products because they have the potential to be contaminated with Salmonella, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people. [ Read more ]
  • Tropical Nut and Fruit Co. Issues Allergy Alert of Undeclared Soy and Tree Nut (Almonds) on Their Truly Good Foods South of the Border Mix

    Charlotte headquartered Tropical Nut and Fruit Co. is voluntarily recalling their 25lb box of Truly Good Foods South of the Border nut mix, Lot #29119, best by date 04/15/2020, item # 102340 and UPC # 094184110198 because it contains undeclared soy and tree nut (al-monds). [ Read more ]
  • White Castle Frozen Food Division Announces Voluntary Recall of a Limited Production of Frozen Sandwiches Sold in Select Grocery Outlets Due to Possible Presence of Listeria Monocytogenes

    White Castle has initiated a voluntary recall of a limited number of frozen 6 pack cheeseburgers, frozen 6 pack hamburgers, frozen 6 pack jalapeno cheeseburgers, and 16 pack hamburgers, 16 pack cheeseburgers for the possible presence of Listeria monocytogenes. [ Read more ]
  • The J. M. Smucker Company Issues Voluntary Recall of Specific Lots of Special Kitty® Wet, Canned Cat Food Due to Health Concerns

    The J. M. Smucker Company today announced a voluntary recall of specific lots of Special Kitty® wet, canned cat food due to health concerns potentially associated with ingredients believed to not meet the Company’s quality and safety standards. [ Read more ]
  • Nassau Candy Distributors Issues Allergy Alert on Undeclared Milk Allergen in Nancy Adams, Dark Chocolate Graham Crackers

    Nassau Candy Distributors of Hicksville, NY is recalling two lots of 7.5 OZ (212g) Nancy Adams, Dark Chocolate Graham Crackers because they may contain undeclared milk allergens. [ Read more ]
  • Dole Fresh Vegetables Announces Precautionary Limited Recall of Colorful Coleslaw

    Dole Fresh Vegetables, Inc. is voluntarily recalling a limited number of cases of Colorful Coleslaw. [ Read more ]
  • Lin’s Waha Int’l Corp Issues Alert on Undeclared Sulfites and Cyclamates in “Suantianyangmei Waxberry and Bingtangyangmei Waxberry”

    Lin’s Waha Int’l Corp of Syosset, NY is recalling its 8.11 OZ (230G) packages of Suantianyangmei Waxberry and Bingtangyangmei Waxberry because they contain undeclared sulfites and cyclamates. [ Read more ]
  • Fuji Food Products, Inc. Voluntarily Recalls Ready-to-Eat Sushi, Salads and Spring Rolls Manufactured on the East Coast Due to Potential Listeria monocytogenes Contamination

    Fuji Food Products, Inc. (Fuji) announced today the voluntary recall of ready to eat sushi, salads and spring rolls sold to select retailers and distributors along the East Coast and Upper Midwest. [ Read more ]
  • UNFI Voluntarily Recalls Wild Harvest® Organic All-Purpose Flour, Unbleached

    UNFI announced today a voluntary national recall of five-pound bags of its Wild Harvest® Organic All-Purpose Flour, Unbleached [ Read more ]
  • Nature’s Rx Issues Voluntary Nationwide Recall of Silver Bullet 10 Male Enhancement Capsules Due to an Undeclared PDE-5 Inhibitor Found in the Product

    Nature’s Rx is voluntarily recalling lot: 01251ZX1, Expiry Date: 11/2022 of Silver Bullet (10 Male Enhancement Capsules). This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil, the active ingredient in Viagra, which is a PDE-5 inhibitor. [ Read more ]
  • Hodgson Mill Issues Voluntary Recall of Unbleached All-Purpose White Wheat Flour Due to Potential Presence of Pathogenic E.coli

    Hodgson Mill of Effingham, IL, announced today a voluntary national recall of specific lots of its Unbleached All-Purpose White Wheat Flour (5 lb.) [ Read more ]
  • B. Braun Medical Inc. Issues Voluntary Nationwide Recall of Twenty-Two (22) Lots of Blood Administration Sets, Due to Potential for Leakage at the Joint Between the Blood Filters and Tubing

    B. Braun Medical Inc. [B. Braun] initiated a voluntary recall of twenty-two (22) lots of Blood Administration Sets. B. Braun identified through complaints and internal discrepancies the potential for leakage at the joint between the blood filters and tubing of these blood administration sets. [ Read more ]
  • Northern Fisheries LTD. Voluntary Expanded Tuna Recall Press Release

    Northern Fisheries LTD of Little Compton, RI, has expanded their voluntary recall of frozen, wild-caught yellowfin Tuna Medallions (product of Vietnam) to include product sold directly to consumers. This recall is due to potentially elevated levels of histamine. [ Read more ]
  • Allergy Alert Issued due to Undeclared Egg in Whole Foods Market Brand Raspberry Cheesecake Italian Gelato

    Whole Foods Market is voluntarily recalling one lot code of Whole Foods Market Raspberry Cheesecake Italian Gelato because these product units contain egg that is not listed on the product label. People who have an allergy or severe sensitivity to egg run the risk of serious or life-threatening alle [ Read more ]
  • Amneal Pharmaceuticals, LLC. Issues Voluntary Nationwide Recall of Ranitidine Tablets, USP, 150mg and 300mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL, Due to Possible Presence of N-nitrosodimethylamine (NDMA) Impurity

    Amneal Pharmaceuticals, LLC. Bridgewater, New Jersey is voluntarily recalling Ranitidine Tablets, 150 mg and 300 mg, and Ranitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL to the consumer level. A listing of the recalled lots is identified below. Ranitidine Tablets, USP, 150 mg and 300 mg [ Read more ]
Twitter Search / FDADeviceInfo
Twitter feed for: FDADeviceInfo. Generated by TwitRSS.me
  • For more information, please visit our “Framework for the Safety and Performance Based Pathway” page: https://go.usa.gov/xpmuR 

    For more information, please visit our “Framework for the Safety and Performance Based Pathway” page: https://go.usa.gov/xpmuR  [ Read more ]
  • Today, the @US_FDA issued a draft guidance on Magnetic Resonance Coils related to the Safety&Performance Based Pathway as part of our commitment to strengthening & modernizing the 510(k) program, as described in the FDA’s Medical Device Safety Action Plan. https://go.usa.gov/xpmuK pic.twitter.com/XrgC0wvhbP

    Today, the @US_FDA issued a draft guidance on Magnetic Resonance Coils related to the Safety&Performance Based Pathway as part of our commitment to strengthening & modernizing the 510(k) program, as described in the FDA’s Medical Device Safety Action Plan. https://go.usa.gov/xpmuK  pic.twitter.com/XrgC0wvhbP [ Read more ]
  • December is #SafeToysAndGiftsMonth. With holiday shopping in full gear, the @US_FDA wants to remind consumers about ways to keep kids safe from toys with lasers. Check out our consumer update on laser toy safety. https://go.usa.gov/xEx2r  #FDA

    December is #SafeToysAndGiftsMonth. With holiday shopping in full gear, the @US_FDA wants to remind consumers about ways to keep kids safe from toys with lasers. Check out our consumer update on laser toy safety. https://go.usa.gov/xEx2r  #FDA [ Read more ]
  • JUST RELEASED: Our Case for Quality program offers a new whitepaper recasting CAPA as a continuous improvement process. Learn more: http://bit.ly/2LleyZs pic.twitter.com/I72EouNT8C

    JUST RELEASED: Our Case for Quality program offers a new whitepaper recasting CAPA as a continuous improvement process. Learn more: http://bit.ly/2LleyZs  pic.twitter.com/I72EouNT8C [ Read more ]
  • It’s National Influenza Vaccination Week— time to highlight the importance flu vaccination! Even though the holiday season has begun, it’s not too late to get a flu vaccine. Protect yourself and your loved ones this flu season. #NIVW #FightFlu https://cdc.gov/flu/prevent/keyfacts.htm …pic.twitter.com/X20vNIK1zx

    It’s National Influenza Vaccination Week— time to highlight the importance flu vaccination! Even though the holiday season has begun, it’s not too late to get a flu vaccine. Protect yourself and your loved ones this flu season. #NIVW #FightFlu https://cdc.gov/flu/prevent/keyfacts.htm … pic.twitter.com/X20vNIK1zx [ Read more ]
  • •Key dates: oJanuary 10, 2020 - Request to make oral presentations oFebruary 12, 2020 - Register to attend the workshop oMarch 26, 2020 - Submit written comments Find out more about the upcoming meeting: https://go.usa.gov/xpPCS 

    •Key dates: oJanuary 10, 2020 - Request to make oral presentations oFebruary 12, 2020 - Register to attend the workshop oMarch 26, 2020 - Submit written comments Find out more about the upcoming meeting: https://go.usa.gov/xpPCS  [ Read more ]
  • On February 25th and 26th, the @US_FDA will host a public workshop, “Evolving Role of Artificial Intelligence in Radiological Imaging.”pic.twitter.com/mPoF1nM9vG

    On February 25th and 26th, the @US_FDA will host a public workshop, “Evolving Role of Artificial Intelligence in Radiological Imaging.” pic.twitter.com/mPoF1nM9vG [ Read more ]
  • The intent of this public workshop is to discuss emerging applications of Artificial Intelligence (AI) in radiological imaging including AI devices intended to automate the diagnostic radiology workflow as well as guided image acquisition.

    The intent of this public workshop is to discuss emerging applications of Artificial Intelligence (AI) in radiological imaging including AI devices intended to automate the diagnostic radiology workflow as well as guided image acquisition. [ Read more ]
  • Artificial intelligence (AI), including machine learning technologies, continues to expand and has the potential to transform healthcare.

    Artificial intelligence (AI), including machine learning technologies, continues to expand and has the potential to transform healthcare. [ Read more ]
  • Shopping from your couch on #CyberMonday? Check out these easy ways to get the whole family moving today! (via @CDCgov) https://go.usa.gov/xpQsC pic.twitter.com/S5h3pQAH59

    Shopping from your couch on #CyberMonday? Check out these easy ways to get the whole family moving today! (via @CDCgov) https://go.usa.gov/xpQsC  pic.twitter.com/S5h3pQAH59 [ Read more ]
  • Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill. Here are our "Food Safety Tips for Healthy Holidays." https://www.fda.gov/consumers/consumer-updates/food-safety-tips-healthy-holidays …

    Parties, family dinners, and other gatherings where food is served are all part of the holiday cheer. But the merriment can change to misery if food makes you or others ill. Here are our "Food Safety Tips for Healthy Holidays." https://www.fda.gov/consumers/consumer-updates/food-safety-tips-healthy-holidays … [ Read more ]
  • During #DiabetesAwarenessMonth, the @US_FDA is reminding people with diabetes against the use of diabetes management devices that are not authorized for sale in the US. Stay informed and find out more: https://go.usa.gov/xpBJC 

    During #DiabetesAwarenessMonth, the @US_FDA is reminding people with diabetes against the use of diabetes management devices that are not authorized for sale in the US. Stay informed and find out more: https://go.usa.gov/xpBJC  [ Read more ]
  • http://HIV.gov  - World AIDS Day #WAD2019http://www.hiv.gov/events/awareness-days/world-aids-day …

    http://HIV.gov  - World AIDS Day #WAD2019 http://www.hiv.gov/events/awareness-days/world-aids-day … [ Read more ]
  • Did you know that you can use your smartphone to access your health records? Learn what #APIs are and how they support #PatientAccess: https://www.healthit.gov/api-education-module/story_html5.html … #HealthITpic.twitter.com/l8zf52vUYe

    Did you know that you can use your smartphone to access your health records? Learn what #APIs are and how they support #PatientAccess: https://www.healthit.gov/api-education-module/story_html5.html … #HealthIT pic.twitter.com/l8zf52vUYe [ Read more ]
  • FDA has approved first system for delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be used w/local anesthesia to treat recurrent ear infections in children.

    FDA has approved first system for delivery of tympanostomy tubes, commonly referred to as ear tubes, that can be used w/local anesthesia to treat recurrent ear infections in children. [ Read more ]
What's New: Drugs RSS Feed
  • Novel Drug Approvals for 2019

    Innovation drives progress. When it comes to innovation in the development of new drugs and therapeutic biological products, FDA’s Center for Drug Evaluation and Research (CDER) supports the pharmaceutical industry at every step of the process. [ Read more ]
  • What's New Related to Drugs

    Want to know what's new on drugs from FDA? This page provides quick links to the latest on a variety of topics including: drug approvals, safety warnings, drug shortages, etc. [ Read more ]
  • MCM-Related Counterterrorism Legislation

    Since September 11, 2001, federal legislation has been enacted to strengthen the nation’s preparedness for responding to public health emergencies involving chemical, biological, radiological, nuclear (CBRN) as well as emerging infectious disease threats. [ Read more ]
  • Drug Safety and Risk Management Advisory Committee Roster

    This page contains the DSARM roster, which lists the current members and the current number of vacancies for the committee. [ Read more ]
  • Patient Listening Sessions

    Patient Listening Sessions led by FDA’s Patient Affairs Staff provide an opportunity for medical product Centers to engage with patients, caregivers, and their advocates about their experience with a disease or condition. [ Read more ]
  • Compounding: Inspections, Recalls, and other Actions

    Human drug compounding; FDA inspections; compounding recalls [ Read more ]
  • FDA Genetic Toxicology Workshop: How Many Doses of an DNA Reactive (Ames-positive) Drug can be Safely Administered to Healthy Subjects? - 11/04/2019 - 11/04/2019

    The topic to be discussed is Healthy subjects receive no benefits from treatment with a DNA-reactive drug and could potentially be exposed to significant health risks. [ Read more ]
  • MannKind Corporation - 578282 - 10/23/2019

    False & Misleading Claims/Misbranded [ Read more ]
  • Biosimilar Product Information

    This page includes a chart of the approved biosimilar and interchangeable products. The approval of biosimilar products can improve access to care for patients by increasing the number of medication options and potentially lower costs. [ Read more ]
  • Newly Added Guidance Documents

    Guidance documents represent the FDA's current thinking on a particular subject. New guidance documents are listed here for three months. [ Read more ]
  • All Guidances for Drugs

    Guidance documents represent the Agency's current thinking on a particular subject. [ Read more ]
  • Development of Locally Applied Corticosteroid Products for the Short-Term Treatment of Symptoms Associated with Internal or External Hemorrhoids Guidance for Industry

    CDER Guidance: Clinical/Medical [ Read more ]
  • Anesthetic and Analgesic Drug Products Advisory Committee Roster

    This page contains the AADPAC roster, which lists the current members and the current number of vacancies for the committee. [ Read more ]
  • Dermatologic and Ophthalmic Drugs Advisory Committee Roster

    This page contains the DODAC roster, which lists the current members and the current number of vacancies for the committee. [ Read more ]
  • December 10, 2019 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement - 12/10/2019 - 12/10/2019

    December 10, 2019 Meeting of the Cardiovascular and Renal Drugs Advisory Committee Meeting Announcement [ Read more ]
Whats New Vaccines Blood Biologics RSS Feed
  • MCM-Related Counterterrorism Legislation

    Since September 11, 2001, federal legislation has been enacted to strengthen the nation’s preparedness for responding to public health emergencies involving chemical, biological, radiological, nuclear (CBRN) as well as emerging infectious disease threats. [ Read more ]
  • Liveyon Labs Inc - 588399 - 12/05/2019

    Deviations/CFR/Regulations for Human Cells, Tissues & Cellular Products (HCT/Ps) [ Read more ]
  • Patient Listening Sessions

    Patient Listening Sessions led by FDA’s Patient Affairs Staff provide an opportunity for medical product Centers to engage with patients, caregivers, and their advocates about their experience with a disease or condition. [ Read more ]
  • What’s New for Biologics

    Latest news from the Center for Biologics Evaluation and Research [ Read more ]
  • CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor

    CPG Sec. 230.150 Blood Donor Classification Statement, Paid or Volunteer Donor [ Read more ]
  • No es demasiado tarde para vacunarse contra la gripe

    ¿Piensa que es demasiado tarde para vacunarse contra la gripe? iEl otoño ya está aquí y es tiempo de vacunarse contra la gripe estacional anual. Lo mejor es vacunarse al comienzo de la temporada de gripe. [ Read more ]
  • Antimicrobial Resistance Information from FDA

    Antimicrobial resistance (AMR)—the ability of a microorganism (bacteria, virus, fungi, parasite) to resist the effects of a drug—is a serious, complex and costly public health problem. Learn what FDA is doing to address AMR. [ Read more ]
  • Licensed Biological Products with Supporting Documents

    Licensed biological products with supporting documents is arranged alphabetically by the proper name of the product(s). Information is provided for original product approvals, new indications, and the current package insert. [ Read more ]
  • Panoscreen EXTEND

    Detection of expected and unexpected red cell blood group antibodies [ Read more ]
  • CBER Reports

    This page contains a summary of regulatory, research, and administrative accomplishments for the last 2 fiscal years and related reports. [ Read more ]
  • Jobs at the Center for Biologics Evaluation and Research (CBER)

    CBER has unique opportunities for individuals with backgrounds in science or administration to fill positions involved in the regulation and research of blood, vaccines and therapeutics. [ Read more ]
  • Physician, Division of Epidemiology (DE) - Title 38(F) Physician (GP-0602)

    The Center for Biologics Evaluation and Research is recruiting to fill a Physician position to serve in the Division of Epidemiology in the Office of Biostatistics and Epidemiology. [ Read more ]
  • Instructions for Completing Form FDA 3500

    Instructions for Completing Form FDA 3500 [ Read more ]
  • BK190389 - ALBAcheck BGS Monoclonal Control

    ALBAcheck® BGS Monoclonal Control is intended for use as a negative control in conjunction with ALBAclone® Blood Grouping reagents (where referenced in the reagent IFU). [ Read more ]
  • Cleared 510(k) Submissions with Supporting Documents - 2019

    List of Cleared 510(k) Submissions with Supporting Documents for 2019 [ Read more ]

News & Events

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  • U.S. Food & Drug Administration (FDA) New and Generic Drug Approvals Calan (verapamil h... Read more>>
  • Proximagen Signs Deal With Upsher-Smith Proximagen Neuroscience plc, a biotechnology company... Read more>>
  • GSK Receives EMEA Approval for Duodart LONDON (AP) - Pharmaceutical company GlaxoSmithKline... Read more>>
  • AllTranz Developing Multi-Use Transdermal Patch   AllTranz, Lexington, Ky., is focused on t... Read more>>
  • Pending Litigation to Delay Launch of Generic Asacol Boehringer Ingelheim’s Roxane Laboratori... Read more>>
  • Mapping Technique Speeds Finding Specific Genes A Purdue University scientist was part of a... Read more>>
  • FDA Approves Mylan’s Drug Applications Mylan Inc. Monday announced that its subsidiary Mylan Ph... Read more>>