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MedWatch Safety Alerts RSS Feed
  • Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing

    Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psy [ Read more ]
  • Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters

    Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. This recall does not affect patients who have successfully u [ Read more ]
  • 2020 Medical Device Recalls

    List of Medical Device recalls in 2020. [ Read more ]
  • ResMed Recalls Stellar 100 and 150 Non-invasive and Invasive Ventilators Due to Sound Alarm Failure

    The ventilators are used on patients that need breathing support. The sound alarm on the ventilator may fail to alert, presenting a risk of injury or death. [ Read more ]
  • Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway

    The system provides heated and humidified breathing gases to patients. The system may malfunction causing water to enter the airway causing serious injury. [ Read more ]
  • Abbott Vascular Recalls NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameter 4.0mm, 4.5mm and 5.00mm) to Deflate

    Coronary dilation catheters are used to open clogged blood vessels to improve blood flow to the heart, Abbot is recalling these devices due to failure of balloon to deflate in certain models, use may cause serious adverse health consequences, such as reduced blow flow to the heart and air embolism. [ Read more ]
  • Belviq, Belviq XR (lorcaserin) by Eisai: Drug Safety Communication - FDA Requests Withdrawal of Weight-Loss Drug

    FDA has requested that the manufacturer voluntarily withdraw the weight-loss drug from the U.S. market because a safety clinical trial shows an increased occurrence of cancer. The drug manufacturer, Eisai Inc,. has submitted a request to voluntarily withdraw the drug. [ Read more ]
  • Medtronic Recalls MiniMed Insulin Pumps for Incorrect Insulin Dosing

    Missing or broken retainer ring could cause under or over delivery of insulin. This may cause patient injury or death. [ Read more ]
  • GE Healthcare Recalls Carestation 600 Series Anesthesia Systems Due to Loss of Mechanical Ventilation

    A loose cable connection could cause the loss of mechanical ventilation which could lead to serious injury or death. [ Read more ]
  • GE Healthcare Recalls CARESCAPE Respiratory Modules Due to Incorrect Oxygen Values

    A manufacturing problem could cause the displayed oxygen values to be incorrect which could lead to serious injury or death. [ Read more ]
  • Efficient Laboratories, Inc. Issues Voluntary Nationwide Recall of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAX due to Microbial Contamination

    Efficient Laboratories, Inc. is voluntarily recalling one lot each of Rompe Pecho EX, Rompe Pecho CF, and Rompe Pecho MAXliquid. Specifically, we are recalling the following lots: Rompe Pecho EX lot 19F332, exp June 2022, Rompe Pecho CF lot 19H359, exp August 2022 and Rompe Pecho MAX lot 19B42, ex [ Read more ]
  • Cybersecurity Vulnerabilities Affecting Medtronic Implantable Cardiac Devices, Programmers, and Home Monitors: FDA Safety Communication

    Regarding cybersecurity vulnerabilities identified in a wireless telemetry technology used for communication between Medtronic’s implantable cardiac devices, clinic programmers, and home monitors. [ Read more ]
  • Clozaril, Fazaclo ODT, Versacloz (clozapine): Drug Safety Communication - FDA Strengthens Warning That Untreated Constipation Can Lead to Serious Bowel Problems

    FDA is strengthening an existing warning that constipation caused by the schizophrenia medicine clozapine (Clozaril, Fazaclo ODT, Versacloz, generics) can, uncommonly, progress to serious bowel complications. This can lead to hospitalization or even death if constipation is not diagnosed/treated. [ Read more ]
  • Distributor Teleflex Recalls the Galemed Babi.Plus Pressure Relief Manifolds Due to Dislodged Valve

    The Babi.Plus Pressure Relief Manifold is used as part of a breathing circuit to assist infant patients to breathe. This device is being recalled due to a dislodged valve resulting in loss of pressure in the system. Teleflex issued a Medical Device Recall Notice to affected customers. [ Read more ]
  • King Systems Issues Recall of King Vision Video Laryngoscope Video Adapter Size 1/2

    King Systems initiated a voluntary recall of One-Hundred Seventy-One (171) units of its King Vision Video Laryngoscope Adapter Size 1/2. The affected products have been found to exhibit a reversed image, which could potentially result in difficulty navigating during intubation and/or delay in intub [ Read more ]
FDA Press Releases RSS Feed
  • Coronavirus Update: FDA steps to ensure quality of foreign products

    Coronavirus Update: FDA steps to ensure quality of foreign products [ Read more ]
  • FDA approves first generic of ProAir HFA

    FDA has approved an application for the first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol. [ Read more ]
  • FDA Authorizes Marketing of the First Genetic Test to Aid in the Diagnosis of Fragile X Syndrome

    Today, FDA authorized marketing of the first test to detect a genetic condition known as Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay and intellectual disability. [ Read more ]
  • FDA Announces Collaborative Review of Scientific Evidence to Support Associations Between Genetic Information and Specific Medications

    FDA is providing its view of the state of the current science in pharmacogenetics. FDA’s new web-based resource describes some of the gene-drug interactions for which it believes there is sufficient scientific evidence to support associations between certain genetic variants & specific medications. [ Read more ]
  • FDA Works to Ensure Smooth Regulatory Transition of Insulin and Other Biological Products

    Today, the U.S. Food and Drug Administration took additional steps to ensure a smooth regulatory transition aimed at increasing patient access to insulin products, as well as certain other biological products set to transition regulatory pathways in March [ Read more ]
  • FDA Takes Action with Indian Government to Protect Consumers From Illicit Medical Products

    The FDA announced that in partnership with the Government of India, approximately 500 shipments of illicit and potentially dangerous, unapproved prescription drugs and combination medical devices were stopped from reaching American consumers. [ Read more ]
  • FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process

    FDA Approves Three Drugs for Nonprescription Use Through Rx-to-OTC Switch Process [ Read more ]
  • FDA’s Actions in Response to 2019 Novel Coronavirus at Home and Abroad

    FDA is an active partner in the COVID-19 response, working closely with government and public health partners across HHS and international counterparts. [ Read more ]
  • FDA Authorizes Marketing of First Cardiac Ultrasound Software That Uses Artificial Intelligence to Guide User

    Today, the U.S. Food and Drug Administration authorized marketing of software to assist medical professionals in the acquisition of cardiac ultrasound, or echocardiography, images. [ Read more ]
  • FDA Expertise Advancing the Understanding of Intentional Genomic Alterations in Animals

    FDA analysis published today advances the understanding of intentional genomic alterations in animals. [ Read more ]
  • FDA Takes Significant Step in Coronavirus Response Efforts, Issues Emergency Use Authorization for the First 2019 Novel Coronavirus Diagnostic

    Today, FDA issued an EUA to enable emergency use of CDC’s 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, this test has been limited to use at CDC laboratories; today’s authorization allows use of the test at any CDC-qualified lab across the country. [ Read more ]
  • FDA and FTC Announce New Efforts to Further Deter Anti-Competitive Business Practices, Support Competitive Market for Biological Products to Help Americans

    The U.S. Food and Drug Administration and the Federal Trade Commission signed a joint statement regarding enhanced collaboration in support of a robust marketplace for biological products. [ Read more ]
  • FDA approves first drug for treatment of peanut allergy for children

    FDA approves first drug for treatment of peanut allergy for children Treatment with this product may be initiated in individuals ages 4 through 17 years with a confirmed diagnosis of peanut allergy and may be continued in individuals 4 years of age and older. [ Read more ]
  • FDA launches mobile-friendly database with information on life-saving HIV drugs as part of ongoing mission to empower the public through increased access to information and data

    FDA launches an interactive database that will offer a wealth of critical information about antiretrovirals (ARVs) eligible for purchase under the President’s Emergency Plan for AIDS Relief (PEPFAR) program. [ Read more ]
  • FDA Continues Strong Support of Innovation in Development of Gene Therapy Products

    FDA Continues Strong Support of Innovation in Development of Gene Therapy Products [ Read more ]
Food and Drugs Administration--Recalls/Safety Alerts
  • Sierra Soups Issues Allergy Alert on Undeclared Gluten in “Pasta e Fagioli” Soup

    Sierra Soups of Fresno, Ca is recalling its 13 ounce packages of "Pasta e Fagioli" because the soup mix contains an individually wrapped package of pasta, which contains gluten [ Read more ]
  • Med Man Expands Voluntary Nationwide Recall of Up2 and Bow & Arrow Due to Presence of Undeclared Sildenafil

    On 11/8/2019, Med Man Distribution voluntarily recalled all lots of Up2 dietary supplement. The recall has expanded to include all lots of dietary supplement Bow and Arrow libido enhancer for men to the consumer level. [ Read more ]
  • Moonstruck Chocolate Issues Allergy Alert on Undeclared Milk in 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate

    Moonstruck Chocolate Co. of Portland, Oregon is recalling 1,500 / 3.1 oz. Praline Pecan & Ginger Element Bar in Dark Chocolate, because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of a serious or life-threatening allergic reaction if they [ Read more ]
  • Taro Pharmaceuticals U.S.A. Issues Voluntary Nationwide Recall of Phenytoin Oral Suspension USP, 125 mg/5ml Due to Possible Underdosing or Overdosing

    Taro Pharmaceuticals U.S.A., Inc. (“Taro” or the “Company”) is voluntarily recalling two (2) lots of Phenytoin Oral Suspension USP, 125 mg/5 mL both in 237 mL bottles, to the consumer level. Phenytoin Oral Suspension USP, 125 mg/5 mL is indicated for the treatment of tonic-clonic (grand mal) and psy [ Read more ]
  • Natural Grocers Issues Recall on Dark Chocolate Almond Clusters

    Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Almond Clusters Dark Chocolate Non-GMO because the product contains undeclared peanut allergen. People who have an allergy or severe sensitivity to peanuts run the [ Read more ]
  • Abbott Initiates Voluntary Recall of Specific Lots of Two Coronary Catheters

    Abbott has voluntarily recalled specific lots of two catheters used in coronary angioplasty procedures: the NC Trek RX Coronary Dilatation Catheter and the NC Traveler Coronary Dilatation Catheter, balloon diameters 4.0mm, 4.5mm and 5.0mm. This recall does not affect patients who have successfully u [ Read more ]
  • Natural Grocers Issues Recall on Dark Chocolate Peanut Clusters

    . Vitamin Cottage Natural Food Markets, Inc., a Lakewood, Colorado-based natural grocery chain, is recalling Natural Grocers brand 8 ounce Peanut Clusters Dark Chocolate Non-GMO because the product contains undeclared almond allergen. People who have an allergy or severe sensitivity to almonds run [ Read more ]
  • Saratoga Potato Chips, LLC Issues Allergy Alert on Undeclared Milk in Kroger Sweet & Mesquite BBQ Potato Chips

    Saratoga Potato Chips, LLC of Fort Wayne, Indiana is recalling 140 cases of Kroger Sweet & Mesquite BBQ Potato Chips because it may contain undeclared milk [ Read more ]
  • CJ Foods Voluntarily Recalls Annie Chun’s Japanese-Style Teriyaki Noodle Bowls Due To Undeclared Peanuts

    CJ Foods, Inc., a division of CJ America, Inc., of La Palma, CA, is voluntarily recalling Annie Chun’s Japanese-Style Teriyaki Noodle Bowls because it may contain undeclared peanuts. Use of this product may cause serious allergic reaction or illness in people who have an allergy or severe sensitivit [ Read more ]
  • Gourmet International and Butlers Chocolates Issue Allergy Alert on Undeclared Milk in Butlers Irish Whiskey Dark Chocolate 3.5 oz Tablet Bar

    Are recalling approximately 1900 units of the IRISH WHISKEY DARK CHOCOLATE 3.5OZ TABLET BAR because it may contain undeclared milk. People who have an allergy or severe sensitivity to milk run the risk of serious allergic reaction or illness if they consume these products. [ Read more ]
  • Save A Lot Issues Allergy Alert on Undeclared Peanuts in Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice-Infused Dried Cranberries & Roasted Sea Salted Cashews Snackers

    Save A Lot is recalling 131 cases of Coburn Farms 4.5oz Sharp Yellow Cheddar Cheese, Cherry Juice- Infused Dried Cranberries & Roasted Sea Salted Cashews Snackers due to a labeling error leading to undeclared peanut allergens in Snackers packages manufactured by Great Lakes Cheese Co. Inc., headquar [ Read more ]
  • Voluntary Recall Notice of Sunny Select Au Jus Gravy Mix 1 oz Pouches Due to Unlabeled Dairy Allergen

    McCormick & Company, Inc. is initiating a voluntary recall of Sunny Select Au Jus Gravy Mix 1 oz pouches due to an unlabeled dairy allergen. [ Read more ]
  • Lotte Int’l America Corp Issues Allergy Alert on Undeclared Almonds in Chocopies

    Lotte Int’l America Corp is recalling its 11.85-ounce packages of “Chocopie” manufactured by Lotte Confectionery Co. Ltd. Korea because of findings of small amount of almond in the product and packaging shows the “manufactured in a facility that also processes peanut & almond”. [ Read more ]
  • Blendtopia Products, LLC Voluntarily Recalls Frozen Smoothie Products Due to Possible Health Risk

    Blendtopia Products, LLC is voluntarily recalling 29,078 cases of 7 ounce frozen Blendtopia brand superfood Smoothie Kits because of potential contamination with Listeria monocytogenes. [ Read more ]
  • Missa Bay LLC Issues Allergy Alert and Recall on Mislabeled Salad Product

    Missa Bay LLC of Swedesboro, N.J. is recalling 1,154 cases of Ready PacⓇ BistroⓇ Bowl Spinach Dijon Salad due to a labeling error leading to the potential for undeclared egg and wheat allergens on a limited number of the salads. The salads contain eggs and wheat, which, while visible through the pac [ Read more ]
Twitter Search / FDADeviceInfo
Twitter feed for: FDADeviceInfo. Generated by TwitRSS.me
  • FDA is an active partner in the #COVID19 response, working closely with our public health partners across @HHSGov and international counterparts, as well as product developers.

    FDA is an active partner in the #COVID19 response, working closely with our public health partners across @HHSGov and international counterparts, as well as product developers. [ Read more ]
  • Today, FDA authorized the first test to detect Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay & intellectual disability. It’s intended as an aid in diagnosing FXS along w/ family history, clinical signs & symptoms.pic.twitter.com/teB7JS5VfZ

    Today, FDA authorized the first test to detect Fragile X Syndrome (FXS), the most common known cause of inherited developmental delay & intellectual disability. It’s intended as an aid in diagnosing FXS along w/ family history, clinical signs & symptoms. pic.twitter.com/teB7JS5VfZ [ Read more ]
  • #NIHchat #RareDiseases #MedicalDevice https://twitter.com/US_FDA/status/1230940696602955781 …

    #NIHchat #RareDiseases #MedicalDevice https://twitter.com/US_FDA/status/1230940696602955781 … [ Read more ]
  • FDA thanks the NIH for letting us participate in their 2020 Rare Disease Twitter Chat. #FDARare2020 #NIHchatpic.twitter.com/U3UU87gF7r

    FDA thanks the NIH for letting us participate in their 2020 Rare Disease Twitter Chat. #FDARare2020 #NIHchat pic.twitter.com/U3UU87gF7r [ Read more ]
  • Are you a rare disease patient, caregiver or advocate with questions or stories to share? Or a researcher with helpful resources? Join us today at 2 pm EST for the @NIH Twitter chat on #RareDiseases. Use #NIHchat to submit your questions. https://go.usa.gov/xpVbT  #RDDNIHpic.twitter.com/WQrYzChIEQ

    Are you a rare disease patient, caregiver or advocate with questions or stories to share? Or a researcher with helpful resources? Join us today at 2 pm EST for the @NIH Twitter chat on #RareDiseases. Use #NIHchat to submit your questions. https://go.usa.gov/xpVbT  #RDDNIH pic.twitter.com/WQrYzChIEQ [ Read more ]
  • Early bird registration is now open for @MDIConline's 2020 Annual Public Forum! Secure your spot today before prices go up on March 14. Register at: http://bit.ly/2XzyRX7 pic.twitter.com/DyEMT1vHPU

    Early bird registration is now open for @MDIConline's 2020 Annual Public Forum! Secure your spot today before prices go up on March 14. Register at: http://bit.ly/2XzyRX7  pic.twitter.com/DyEMT1vHPU [ Read more ]
  • Find out more about pharmacogenetic associations. https://go.usa.gov/xdPCW 

    Find out more about pharmacogenetic associations. https://go.usa.gov/xdPCW  [ Read more ]
  • The @US_FDA is introducing a new resource providing our view of certain established gene-drug interactions that appear in FDA-approved drug labeling and additional gene-drug interactions that are consistent with current labeling and supported by sufficient scientific evidence.pic.twitter.com/z0qsdho1BV

    The @US_FDA is introducing a new resource providing our view of certain established gene-drug interactions that appear in FDA-approved drug labeling and additional gene-drug interactions that are consistent with current labeling and supported by sufficient scientific evidence. pic.twitter.com/z0qsdho1BV [ Read more ]
  • There are no FDA-approved drugs to treat #COVID19 or other coronaviruses. Products claiming otherwise should be reported to FDA. #COVID19Fraud #coronavirus https://www.fda.gov/safety/report-problem-fda/reporting-unlawful-sales-medical-products-internet …

    There are no FDA-approved drugs to treat #COVID19 or other coronaviruses. Products claiming otherwise should be reported to FDA. #COVID19Fraud #coronavirus https://www.fda.gov/safety/report-problem-fda/reporting-unlawful-sales-medical-products-internet … [ Read more ]
  • Are you a rare disease patient, caregiver or advocate with questions or stories to share? Or a researcher with helpful resources? Join @NIHDirector, @NIH and @ncats_nih_gov for a Twitter chat using #NIHchat on 2/21 from 2-3 p.m. ET! https://go.usa.gov/xpVbT  #RDDNIHpic.twitter.com/muxqIKYBAT

    Are you a rare disease patient, caregiver or advocate with questions or stories to share? Or a researcher with helpful resources? Join @NIHDirector, @NIH and @ncats_nih_gov for a Twitter chat using #NIHchat on 2/21 from 2-3 p.m. ET! https://go.usa.gov/xpVbT  #RDDNIH pic.twitter.com/muxqIKYBAT [ Read more ]
  • This issue is due to weaker material close to the balloon bond resulting from excessive exposure to heat during manufacturing. Find out more about the #MedicalDevice recall. https://go.usa.gov/xdU5w 

    This issue is due to weaker material close to the balloon bond resulting from excessive exposure to heat during manufacturing. Find out more about the #MedicalDevice recall. https://go.usa.gov/xdU5w  [ Read more ]
  • Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Abbott Vascular Recalls the NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameters 4.0mm, 4.5mm and 5.0mm) to Deflate.pic.twitter.com/GrLYCw1H3n

    Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Abbott Vascular Recalls the NC Trek RX and NC Traveler RX Coronary Dilatation Catheters Due to Failure of Balloon (diameters 4.0mm, 4.5mm and 5.0mm) to Deflate. pic.twitter.com/GrLYCw1H3n [ Read more ]
  • The system provides heated and humidified breathing gases to patients. The system may malfunction causing water to enter the airway causing serious injury. Find out more about the #MedicalDevice recall. https://go.usa.gov/xdU9Y 

    The system provides heated and humidified breathing gases to patients. The system may malfunction causing water to enter the airway causing serious injury. Find out more about the #MedicalDevice recall. https://go.usa.gov/xdU9Y  [ Read more ]
  • Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway.pic.twitter.com/lbZJLpL8Wl

    Today, the @US_FDA identified a Class I Recall, the most serious type of recall: Teleflex Medical Recalls Comfort Flo Humidification Systems Due to Malfunction That May Cause Water to Enter Airway. pic.twitter.com/lbZJLpL8Wl [ Read more ]
  • The ventilators are used on patients that need breathing support. The sound alarm on the ventilator may fail to alert, presenting a risk of injury or death. Find out more about the recall. https://go.usa.gov/xdUW3 

    The ventilators are used on patients that need breathing support. The sound alarm on the ventilator may fail to alert, presenting a risk of injury or death. Find out more about the recall. https://go.usa.gov/xdUW3  [ Read more ]
What's New: Drugs RSS Feed
  • Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979

    Guidance for Industry, Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979 [ Read more ]
  • FDA approves first generic of ProAir HFA

    FDA has approved an application for the first generic of ProAir HFA (albuterol sulfate) Inhalation Aerosol. [ Read more ]
  • First Generic Drug Approvals

    Each year, FDA’s Center for Drug Evaluation and Research (CDER) approves a wide range of new drug products. FDA provides the scientific and regulatory advice needed to bring safe, effective, high-quality generic alternatives to market, which in turn creates more affordable treatment options for patients. “First generics” are just what they sound like—the first approval by FDA which permits a manufacturer to market a generic drug product in the United States. [ Read more ]
  • Remarks by Dr. Hahn to the Public Meeting on Rare Diseases - 02/24/2020 -

    Remarks by Dr. Hahn to the Public Meeting on Rare Diseases [ Read more ]
  • Real World Evidence - From Safety to a Potential Tool for Advancing Innovative Ways to Develop New Medical Therapies

    Real World Evidence --- From Safety to a Potential Tool for Advancing Innovative Ways to Develop New Medical Therapies with Jacqueline Corrigan-Curay and David Martin [ 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 ]
  • Generic Drugs Guidances & Reports

    The research studies conducted under Generic Drug User Fee Amendments (GDUFA) initiatives support development of general and product-specific guidances for industry to efficiently develop new generic products. OGD also publishes an annual research report each fiscal year, summarizing the research activities and outcomes from both extramural and intramural projects. [ 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 ]
  • 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 ]
  • Rare Disease Day 2020: FDA Continues Important Work on Treatments for Rare Diseases

    FDA is undertaking a number of efforts to advance the development of medical products to meet the needs of the rare disease population. [ Read more ]
  • CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices

    Document issued on October 3, 2006 and supersedes Compliance Policy Guide (CPG) “Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16)” that was issued in March 1995. [ Read more ]
  • Therapeutic Biologics Applications (BLA)

    Therapeutic Biologics Applications (BLA) [ Read more ]
  • Resources for Information | Approved Drugs

    FDA provides online resources for information on approved drugs for consumers and health care professionals--including links to Orange Book and Drugs@FDA. [ Read more ]
  • Background Information: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book)

    Background Information: Lists of Licensed Biological Products with Reference Product Exclusivity and Biosimilarity or Interchangeability Evaluations (Purple Book) [ Read more ]
  • 2018 Meeting Materials, Pulmonary-Allergy Drugs Advisory Committee

    Meeting materials for the Pulmonary-Allergy Drugs Advisory Committee meetings for 2018, including the meeting announcement, briefing materials, committee roster, webcast information, agenda, committee questions, meeting roster, presentation slides, summary minutes, and transcript. [ Read more ]
Whats New Vaccines Blood Biologics RSS Feed
  • Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979

    Guidance for Industry, Good Laboratory Practice Regulations Management Briefings, Post Conference Report, Aug 1979 [ Read more ]
  • Remarks by Dr. Hahn to the Public Meeting on Rare Diseases - 02/24/2020 -

    Remarks by Dr. Hahn to the Public Meeting on Rare Diseases [ Read more ]
  • Section 8100: Communication

    This is the CBER SOPP Section 8100: Communication main page. [ Read more ]
  • Biologics PREA Reviews and Labeling Changes

    PREA Labeling Changes, Medical, Statistical, and Clinical Pharmacology Reviews of Pediatric Studies Conducted under Section 505B of the Federal Food, Drug, and Cosmetic Act (the Act), as amended by the FDA Amendments Act of 2007 (FDAAA). These assessments are for CBER regulated drugs approved under section 505 of the Act and biological drugs licensed under section 351 of the Public Health Service Act. [ Read more ]
  • Section 8400: Marketing Applications

    This is the SOPP Section 8400: Marketing Applications main page. [ Read more ]
  • Rare Disease Day 2020: FDA Continues Important Work on Treatments for Rare Diseases

    FDA is undertaking a number of efforts to advance the development of medical products to meet the needs of the rare disease population. [ Read more ]
  • CPG Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices

    Document issued on October 3, 2006 and supersedes Compliance Policy Guide (CPG) “Sec. 100.550 Status and Responsibilities of Contract Sterilizers Engaged in the Sterilization of Drugs and Devices (CPG 7150.16)” that was issued in March 1995. [ Read more ]
  • Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay

    This is the Class II Special Controls Guidance Document: In Vitro HIV Drug Resistance Genotype Assay. [ Read more ]
  • Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container

    Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container, CBER, Biologics, Development Stage, Guidance for Industry: Class II Special Controls Guidance Document: Cord Blood Processing System and Storage Container, CBER, Biologics [ Read more ]
  • Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle

    This is the Guidance for Industry and FDA Staff: Class II Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle. [ Read more ]
  • Emergency Use Authorization

    The Emergency Use Authorization (EUA) authority allows FDA to help strengthen the nation’s public health protections against CBRN threats by facilitating the availability and use of MCMs needed during public health emergencies [ Read more ]
  • Vaccines Licensed for Use in the United States

    The product name and trade name of vaccines licensed for use in the United States. [ Read more ]
  • Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product

    Guidance for Industry and FDA Staff - Submission and Resolution of Formal Disputes Regarding the Timeliness of Premarket Review of a Combination Product [ Read more ]
  • Health Fraud Scams

    Learn how to spot health fraud and avoid it. [ Read more ]
  • What’s New for Biologics

    Latest news from the Center for Biologics Evaluation and Research [ Read more ]

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