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MedWatch Safety Alerts RSS Feed

  • Medtronic Recalls HVAD Pump Implant Kits Due to Delayed or Failed Restart After the Pump is Stopped

    The HeartWare HVAD system pump is used in patients with heart failure. Some pumps had delayed or failed restarts, which may cause serious risk to patients. [ Read more ]

  • 2021 Medical Device Recalls

    List of Medical Device recalls in 2021. [ Read more ]

  • Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System

    Medtronic plc , the global leader in medical technology, has voluntarily issued a global recall of unused Medtronic Valiant Navion™ thoracic stent graft system and informed physicians to immediately cease use of the device until further notice. [ Read more ]

  • Hillrom Recalls Liko Multirall 200 Overhead Lift Due to Failure to Properly Attach Q-Link Strap Lock (Also Known as Q-Link 1 Strap Lock) to S65 Hook

    The Liko Multirall 200 Overhead Lift is a general-purpose lift to move patients from room to room. [ Read more ]

  • 2021 Safety Communications

    The FDA posts Medical Device Safety Communications to describe the FDA's current analysis of an issue and contain specific regulatory approaches and clinical recommendations for patient management. [ Read more ]

  • Boston Scientific Corporation Recalls EMBLEM S-ICD (Subcutaneous Implantable Cardioverter Defibrillator) System Due to Risk of Short-Circuit

    EMBLEM S-ICD is an implantable defibrillator. In some devices, moisture may get inside and keep the device from shocking the heart to fix heart rhythm. [ Read more ]

  • Pulse Oximeter Accuracy and Limitations: FDA Safety Communication

    The FDA is informing patients and health care providers that pulse oximeters have limitations and a risk of inaccuracy that must be considered. [ Read more ]

  • Adamssecret.co Issues Voluntary Nationwide Recall of Adam’s Secret Extra Strength 1500 and 3000 Capsules Due to Presence of Undeclared Sildenafil and/or Tadalafil

    Adamssecret.co is voluntarily recalling all lots within expiry of Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil and/or tadalafi [ Read more ]

  • Boston Scientific Recalls EMBLEM S-ICD Subcutaneous Electrode (Model 3501) Due to Risk of Fractures

    EMBLEM S-ICD Subcutaneous Electrode (Model 3501) is part of the Boston Scientific S-ICD System that helps detect heart activity and provides defibrillation therapy. [ Read more ]

  • Smiths Medical Recalls Medfusion 3500 and 4000 Syringe Pumps Due to Risk of Medication Delivery Error

    Medfusion 3500 and 4000 syringe pumps control fluid and drug delivery to patients. A software issue may cause over- or under- delivery, causing adverse events. [ Read more ]

  • Using Ventilator Splitters During the COVID-19 Pandemic - Letter to Health Care Providers

    The FDA is informing that recent literature indicates that certain features are associated with better performance. [ Read more ]

  • Xeljanz, Xeljanz XR (tofacitinib): Drug Safety Communication - Initial Safety Trial Results Find Increased Risk of Serious Heart-related Problems and Cancer with Arthritis and Ulcerative Colitis Medicine

    The FDA is alerting the public that preliminary results from a safety clinical trial show an increased risk of serious heart-related problems and cancer with the arthritis and ulcerative colitis medicine Xeljanz, Xeljanz XR (tofacitinib) compared to tumor necrosis factor (TNF) inhibitors. [ Read more ]

  • Apotex Corp. Issues Voluntary Nationwide Recall of Enoxaparin Sodium Injection, USP Due to Mislabeling of Syringe Barrel Measurement Markings

    Apotex Corp is voluntarily recalling two (2) batches of Enoxaparin Sodium Injection, USP to consumer level due to a packaging error resulting in some syringes barrels containing 150 mg/mL markings (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL stre [ Read more ]

  • Penumbra’s Urgent Voluntary Recall of JET 7 Catheters with Xtra Flex Technology Due to Increased Risk of Mortality and Serious Injury – Urgent Letter to Health Care Providers

    Penumbra has issued an urgent recall of all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology (JET 7 Xtra Flex) based on the risk of unexpected death or serious injury while used for removing clots in stroke patients [ Read more ]

  • Penumbra’s Recall of the JET 7 Reperfusion Catheter Due to Distal Tip Damage

    The device is used in patients experiencing a stroke. The distal tip may become damaged, which may result in serious injury or death. [ Read more ]
FDA Press Releases RSS Feed

  • Coronavirus (COVID-19) Update: March 2, 2021

    Coronavirus (COVID-19) Update: March 2, 2021 [ Read more ]

  • FDA Authorizes First Robotically-Assisted Surgical Device for Performing Transvaginal Hysterectomy

    FDA authorizes marketing of the Hominis Surgical System, a new robotically-assisted surgical device (RASD) that can help facilitate transvaginal hysterectomy in certain patients. [ Read more ]

  • Coronavirus (COVID-19) Update: FDA Issues Authorization for Quidel QuickVue At-Home COVID-19 Test

    The U.S. Food and Drug Administration issued an emergency use authorization (EUA) for the Quidel QuickVue At-Home COVID-19 Test. [ Read more ]

  • FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

    The FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older. [ Read more ]

  • FDA Statement on Vaccines and Related Biological Products Advisory Committee Meeting

    Following a positive advisory committee meeting outcome regarding the Janssen Biotech Inc. COVID-19 vaccine, the U.S. Food and Drug Administration has informed the sponsor that it will rapidly work toward finalization and issuance of an emergency use authorization [ Read more ]

  • FDA Approves First Treatment for Molybdenum Cofactor Deficiency Type A

    FDA approves treatment for Molybdenum Cofactor Deficiency Type A, a rare metabolic disorder characterized by severe and rapidly progressive neurologic damage. [ Read more ]

  • Coronavirus (COVID-19) Update: February 26, 2021

    Coronavirus (COVID-19) Update: February 26, 2021 [ Read more ]

  • FDA Authorizes Marketing of Novel Device to Help Protect Athletes’ Brains During Head Impacts

    FDA has authorized marketing of a new device intended to be worn around the neck of athletes aged 13 years and older during sports activities to aid in the protection of the brain from the effects associated with repetitive sub-concussive head impacts. [ Read more ]

  • Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

    Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine [ Read more ]

  • FDA Approves Targeted Treatment for Rare Duchenne Muscular Dystrophy Mutation

    The FDA has granted approval for an injection for the treatment of Duchenne muscular dystrophy (DMD) in patients who have a confirmed mutation of the DMD gene that is amenable to exon 45 skipping (Exons are pieces of DNA that provide information for making proteins in a person’s genome). [ Read more ]

  • Coronavirus (COVID-19) Update: February 23, 2021

    Coronavirus (COVID-19) Update: February 23, 2021 [ Read more ]

  • Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants

    Coronavirus (COVID-19) Update: FDA Issues Policies to Guide Medical Product Developers Addressing Virus Variants [ Read more ]

  • FDA Warns 10 Companies for Illegally Selling Dietary Supplements Claiming to Treat Depression and Other Mental Health Disorders

    FDA announced warning letters to 10 companies for illegally selling dietary supplements that claim to cure, treat, mitigate, or prevent depression and other mental health disorders, in violation of the Federal Food, Drug, and Cosmetic Act (FD&C Act). [ Read more ]

  • Coronavirus (COVID-19) Update: February 19, 2021

    Coronavirus (COVID-19) Update: February 19, 2021 [ Read more ]

  • COVID-19 Update: USDA, FDA Underscore Current Epidemiologic and Scientific Information Indicating No Transmission of COVID-19 Through Food or Food Packaging

    USDA, FDA underscore epidemiologic and scientific information indicating no transmission of COVID-19 Through Food or Food Packaging [ Read more ]
Food and Drugs Administration--Recalls/Safety Alerts

  • El Abuelito Expands Recall to Include Queso Fresco, Quesillo, and Requeson Products Because of Possible Health Risk

    El Abuelito Cheese of Paterson, NJ is recalling all Queso Fresco (Fresh, soft cheese), Quesillo (Oaxaca, string cheese), and Requeson (Ricotta) products, because it has the potential to be contaminated with Listeria monocytogenes [ Read more ]

  • The Quaker Oats Company Issues Voluntary Recall of Quaker Rice Crisps Sweet Barbecue Flavor Due to Undeclared Soy Issue

    The Quaker Oats Company, a subsidiary of PepsiCo, Inc., today issued a voluntary recall for 3.03 oz. bags of Quaker Rice Crisps Sweet Barbecue Flavor because they may contain undeclared soy ingredients. [ Read more ]

  • J&J Distributing (owned by New Harvest Foods) Recalls Multiple Products Because of Possible Health Risk

    J&J Distributing of St. Paul, MN, is recalling multiple products because they have the potential to be contaminated with Listeria monocytogenes [ Read more ]

  • Vitakraft Sun Seed Recall of Vitakraft Vita Smart Hedgehog Food Due to Possible Salmonella Health Risk

    Vitakraft Sun Seed Inc. of Weston, OH, is voluntarily recalling one lot of Vitakraft Vita Smart Hedgehog Food because it has the potential to be contaminated with Salmonella. Salmonella can affect animals eating the products and there is risk to humans from handling contaminated pet products, especi [ Read more ]

  • Medtronic Announces Voluntary Recall of Unused Valiant Navion™ Thoracic Stent Graft System

    Medtronic plc , the global leader in medical technology, has voluntarily issued a global recall of unused Medtronic Valiant Navion™ thoracic stent graft system and informed physicians to immediately cease use of the device until further notice. [ Read more ]

  • Urban Remedy Voluntarily Recalls Beverages with Undeclared Almond & Cashew Allergens

    Urban Remedy, a California-based producer and retailer of ultra-fresh, organic meals, is voluntarily recalling 462 beverages because it may contain undeclared almonds and cashews. [ Read more ]

  • Market District Voluntarily Recalls Gourmet Chocolate Covered Pretzels Due to Undeclared Pecan Allergen

    Giant Eagle, Inc. has issued a voluntarily recall of Market District Gourmet Pretzel Platters and Gourmet Pretzel Bags due to the possibility the product may contain an undeclared pecan allergen. Those who have an allergy or severe sensitivity to pecans could experience a serious or life-threatening [ Read more ]

  • El Abuelito Recalls Queso Fresco Products Because of Possible Health Risk

    El Abuelito Cheese of Paterson, NJ is recalling all Queso Fresco (Fresh, soft cheese) products, because it has the potential to be contaminated with Listeria monocytogenes, an organism which can cause serious and sometimes fatal infections in young children, frail or elderly people, and others with [ Read more ]

  • El Abuelito Retira Del Mercado Productos de Queso Fresco por Posible Riesgo a la Salud

    El Abuelito Cheese de Paterson, NJ, está retirando del mercado todos los productos de queso fresco (queso fresco, suave), porque pueden estar potencialmente contaminados con Listeria monocytogenes, un organismo que puede causar infecciones graves y, a veces, fatales en niños pequeños, personas frági [ Read more ]

  • Litehouse Inc. Issues Allergy Alert on Undeclared Anchovies in Product

    Litehouse Inc. is voluntarily recalling a limited quantity of its Brite Harbor Caesar Dressing & Dip 1.5 oz pillows because it may contain undeclared anchovies. The Food and Drug Administration has been made aware of this recall which is limited to one production day from a single manufacturing loca [ Read more ]

  • Adamssecret.co Issues Voluntary Nationwide Recall of Adam’s Secret Extra Strength 1500 and 3000 Capsules Due to Presence of Undeclared Sildenafil and/or Tadalafil

    Adamssecret.co is voluntarily recalling all lots within expiry of Adam’s Secret Extra Strength 1500 and Adam’s Secret Extra Strength 3000 capsules to the consumer level. This recall has been initiated after an FDA laboratory analysis found the product to contain undeclared sildenafil and/or tadalafi [ Read more ]

  • NDAL MFG INC Issues Voluntary Nationwide Recall of ManukaGuard Allercleanse Nasal Spray Due to Contamination with Yeast

    NDAL MFG INC is voluntarily recalling one lot of Manukaguard Allercleanse, nasal spray to the consumer level. The Allercleanse nasal sprays have been found to be contaminated with yeast. [ Read more ]

  • Hickory Harvest Foods Issues Allergy Alert on Undeclared Almonds in Sprouts Vanilla Flavored Yogurt Covered Cranberries

    Hickory Harvest Foods of Akron, OH is recalling Vanilla Flavored Yogurt Covered Cranberries manufactured under the brand of Sprouts Farmers Market because they may contain undeclared Almonds. People who have an allergy or severe sensitivity to Almonds run the risk of serious or life- threatening al [ Read more ]

  • Dole Fresh Vegetables, Inc. Is Voluntarily Recalling Two Lot Codes of Dole™ Sunflower Crunch Chopped Salad Kit

    Dole Fresh Vegetables, Inc. is voluntarily recalling two lot codes of Dole™ Sunflower Crunch Chopped Salad Kit. This recall is due to possible undeclared allergens (wheat and tree nuts) in Dole™ Sunflower Crunch Chopped Salad Kit. The dressing and topping kit (masterpack) designed for a different Do [ Read more ]

  • Delicae Gourmet LLC Issues Allergy Alert on Undeclared Shrimp Allergen in Thai Peanut Sauce, Panang Curry Sauce, and Spicy Red Curry Sauce

    Delicae Gourmet LLC of Tarpon Springs, FL is recalling Thai Peanut Sauce, Panang Curry Sauce, and Spicy Red Curry Sauce, because it contains undeclared shrimp allergen. People who have an allergy or severe sensitivity to shrimp run the risk of serious or life-threatening allergic reaction if they c [ Read more ]
Twitter Search / fdadeviceinfo
Twitter feed for: fdadeviceinfo. Generated by TwitRSS.me

  • REMINDER. twitter.com/FDADeviceInfo/…

    REMINDER. twitter.com/FDADeviceInfo/… [ Read more ]

  • The @US_FDA will share information and answer questions about EUAs for respirators, importing respirators, and overall FDA actions to help assure health care personnel on the front lines have the necessary supplies of respirators to meet the demand. go.usa.gov/xwBRh

    The @US_FDA will share information and answer questions about EUAs for respirators, importing respirators, and overall FDA actions to help assure health care personnel on the front lines have the necessary supplies of respirators to meet the demand. go.usa.gov/xwBRh [ Read more ]

  • On Tuesday, June 9, 12:00-1:00 pm ET, the @US_FDA will kick off a webinar series on the topic of Respirators for Health Care Personnel Use during COVID-19 Pandemic. pic.twitter.com/c5fWbEtiYO

    On Tuesday, June 9, 12:00-1:00 pm ET, the @US_FDA will kick off a webinar series on the topic of Respirators for Health Care Personnel Use during COVID-19 Pandemic. pic.twitter.com/c5fWbEtiYO [ Read more ]

  • Testing is crucial to guiding our next steps in the fight against #COVID19, but do you know the difference between all the tests available? fda.gov/coronavirus pic.twitter.com/CBgBBuM5IM

    Testing is crucial to guiding our next steps in the fight against #COVID19, but do you know the difference between all the tests available? fda.gov/coronavirus pic.twitter.com/CBgBBuM5IM [ Read more ]

  • Due to the risk of exposure to harmful cyanide gas when certain transport media is used w/ an incompatible testing platform or laboratory processes, the @US_FDA is reminding laboratory staff to use compatible transport media w/ SARS-CoV-2 Testing Platforms go.usa.gov/xwZnh pic.twitter.com/k1YdO58Z91

    Due to the risk of exposure to harmful cyanide gas when certain transport media is used w/ an incompatible testing platform or laboratory processes, the @US_FDA is reminding laboratory staff to use compatible transport media w/ SARS-CoV-2 Testing Platforms go.usa.gov/xwZnh pic.twitter.com/k1YdO58Z91 [ Read more ]

  • This resource includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a test. Find out more. go.usa.gov/xwZ2U To use the resource, download the file, open it, and click Slide Show

    This resource includes validated supply alternatives that labs can use to continue performing testing when there is a supply issue with some components of a test. Find out more. go.usa.gov/xwZ2U To use the resource, download the file, open it, and click Slide Show [ Read more ]

  • The @US_FDA has released a new web resource for labs performing #COVID19 tests that are authorized under an Emergency Use Authorization (EUA). pic.twitter.com/D1rJottZS3

    The @US_FDA has released a new web resource for labs performing #COVID19 tests that are authorized under an Emergency Use Authorization (EUA). pic.twitter.com/D1rJottZS3 [ Read more ]

  • Medtronic has recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process. Find out more about this #MedicalDevice recall. go.usa.gov/xwWCk

    Medtronic has recalled the auto-registration feature of the StealthStation DBS Software due to inaccuracies caused by minor patient movements during the auto-registration process. Find out more about this #MedicalDevice recall. go.usa.gov/xwWCk [ Read more ]

  • On June 1st, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures. pic.twitter.com/mGsbP4C8be

    On June 1st, the @US_FDA identified a Class I Recall, the most serious type of recall: Medtronic recalls StealthStation auto-registration feature due to inaccuracies during deep brain stimulation (DBS) procedures. pic.twitter.com/mGsbP4C8be [ Read more ]

  • We apologize for the issues you experienced with participating in today's Town Hall call. We will make sure the transcript from today's call is available by June 9th.

    We apologize for the issues you experienced with participating in today's Town Hall call. We will make sure the transcript from today's call is available by June 9th. [ Read more ]

  • We apologize for today's technical difficulties. A transcript from today's Town Hall will be available by June 9th. We have also confirmed the dial-in information for our next Town Hall call on June 10, 2020 is correct.

    We apologize for today's technical difficulties. A transcript from today's Town Hall will be available by June 9th. We have also confirmed the dial-in information for our next Town Hall call on June 10, 2020 is correct. [ Read more ]

  • We apologize for the technical difficulties for today's Town Hall. We will make sure the transcript from today's call is available by June 9th.

    We apologize for the technical difficulties for today's Town Hall. We will make sure the transcript from today's call is available by June 9th. [ Read more ]

  • We apologize for the difficulties you experienced with participating in today's Town Hall call. We will make sure the transcript from today's call is available by June 9th. We've also confirmed the dial-in information for our June 10th call is accurate.

    We apologize for the difficulties you experienced with participating in today's Town Hall call. We will make sure the transcript from today's call is available by June 9th. We've also confirmed the dial-in information for our June 10th call is accurate. [ Read more ]

  • Emergency department data collected by CDC surveillance networks indicate some patients may be delaying emergency care during the #COVID19 pandemic. Fewer visits for critical conditions might result in complications or death. Learn more from @CDCMMWR: bit.ly/MMWR6320. pic.twitter.com/Z6tUdtTVL7

    Emergency department data collected by CDC surveillance networks indicate some patients may be delaying emergency care during the #COVID19 pandemic. Fewer visits for critical conditions might result in complications or death. Learn more from @CDCMMWR: bit.ly/MMWR6320. pic.twitter.com/Z6tUdtTVL7 [ Read more ]

  • REMINDER twitter.com/FDADeviceInfo/…

    REMINDER twitter.com/FDADeviceInfo/… [ Read more ]
What's New: Drugs RSS Feed

  • Novel Drug Approvals for 2021

    The availability of new drugs and biological products often means new treatment options for patients and advances in health care for the American public [ Read more ]

  • Vanda Pharmaceuticals - 576442 - 11/21/2018

    Vanda Pharmaceuticals Close Out Letter [ Read more ]

  • Vanda Pharmaceuticals - 576442 - 10/22/2018

    False & Misleading Claims/Misbranded [ Read more ]

  • Nephron SC Inc. - 610867 - 09/22/2020

    False & Misleading Claims/Misbranded [ Read more ]

  • Drug Master File (DMF) and Drug Substance Workshop - 03/03/2021 - 03/04/2021

    Drug Master File (DMF) and Drug Substance Workshop [ 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 ]

  • Coronavirus (COVID-19) Update: March 2, 2021

    Coronavirus (COVID-19) Update: March 2, 2021 [ Read more ]

  • Roadmap to 2030 for New Drug Evaluation in Older Adults - 03/23/2021 - 03/23/2021

    Roadmap to 2030 for New Drug Evaluation in Older Adults March 23, 2021 [ Read more ]

  • FDA Voices

    Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement. [ Read more ]

  • FDA Voices on Consumer Safety and Enforcement

    FDA Voices on Consumer Safety and Enforcement [ Read more ]

  • National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams

    The FDA is well-equipped to identify and thwart medical product scams while vaccine distribution is underway throughout the country. [ Read more ]

  • User Fee Lists

    Fiscal Year (FY) 2017 GDUFA facility fees are due on October 3, 2016. [ Read more ]

  • Generic Drug Facilities, Sites and Organization Lists

    Generic Drug Facilities, Sites and Organization Lists [ Read more ]

  • Competitive Generic Therapy Approvals

    A list of all FDA-approved abbreviated new drug applications for drug products that received a Competitive Generic Therapy designation under section 506H of the Federal Food, Drug, and Cosmetic Act. [ Read more ]

  • Health Fraud Scams

    Learn how to spot health fraud and avoid it. [ Read more ]
Whats New Vaccines Blood Biologics RSS Feed

  • Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine

    Coronavirus (COVID-19) Update: FDA Allows More Flexible Storage, Transportation Conditions for Pfizer-BioNTech COVID-19 Vaccine [ Read more ]

  • Coronavirus (COVID-19) Update: March 2, 2021

    Coronavirus (COVID-19) Update: March 2, 2021 [ Read more ]

  • FDA Issues Emergency Use Authorization for Third COVID-19 Vaccine

    The FDA issued an emergency use authorization (EUA) for the third vaccine for the prevention of coronavirus disease 2019 (COVID-19). The EUA allows the Janssen COVID-19 Vaccine to be distributed in the U.S for use in individuals 18 years of age and older. [ Read more ]

  • FDA Voices

    Insights into the agency's work in the areas of medical products, food, tobacco, policy, consumer safety and enforcement. [ Read more ]

  • FDA Voices on Consumer Safety and Enforcement

    FDA Voices on Consumer Safety and Enforcement [ Read more ]

  • National Consumer Protection Week: FDA Is Vigilant in Protecting Consumers Against COVID-19 Vaccine Scams

    The FDA is well-equipped to identify and thwart medical product scams while vaccine distribution is underway throughout the country. [ Read more ]

  • Health Fraud Scams

    Learn how to spot health fraud and avoid it. [ Read more ]

  • Patient Listening Sessions

    Patient Listening Sessions led by FDA’s Office of Patient Affairs 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 ]

  • Vaccines and Related Biological Products Advisory Committee March 5, 2021 Meeting Announcement - 03/05/2021 - 03/05/2021

    This is the CBER Vaccines and Related Biological Products Advisory Committee March 5, 2021 Meeting Announcement. [ Read more ]

  • What’s New for Biologics

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

  • Update on Amyotrophic Lateral Sclerosis (ALS) Product Development

    This page describes the Update on Amyotrophic Lateral Sclerosis (ALS) Product Development [ Read more ]

  • COVID-19 Vaccines

    FDA has rigorous scientific and regulatory processes in place to facilitate development and ensure the safety, effectiveness and quality of COVID-19 vaccines. [ Read more ]

  • Consumer Updates

    Science-based health and safety information you can trust. [ Read more ]

  • Rare Disease Day 2021: FDA Shows Sustained Support of Rare Disease Product Development During the Public Health Emergency

    As the FDA focuses on the COVID-19 pandemic, the agency also remains dedicated to its crucial role in development of treatments for rare diseases. [ Read more ]

  • Cellular & Gene Therapy Products

    CBER provides oversight of clinical studies, proactive scientific and regulatory advice to medical researchers and manufacturers of cellular therapy products, human gene therapy products, and certain devices related to cell and gene therapy. [ Read more ]

News & Events

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  • in vivo Pharmacodynamic Assay Trevigen offers a validated assay with higher sensitivity and... Read more>>
  • U.S. Food & Drug Administration (FDA) New and Generic Drug Approvals Calan (verapamil h... Read more>>
  • FDA Requests More Information on Certriad LONDON (AP) - AstraZeneca PLC and Abbott Laborator... Read more>>
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  • Pending Litigation to Delay Launch of Generic Asacol Boehringer Ingelheim’s Roxane Laboratori... Read more>>
  • T Cell Proliferation Assays ProImmune Ltd, a leader in epitope discovery, immunogenicity, an... Read more>>

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