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CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.

latest-news

FDA says the Boston Scientific recall of its ENROUTE Transcarotid Neuroprotection System is Class 1.

LATEST NEWS

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HHS to Appoint 2 New FDA Deputy Commissioners: CNBC

CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.

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Boston Scientific ENROUTE System Recall is Class 1

FDA says the Boston Scientific recall of its ENROUTE Transcarotid Neuroprotection System is Class 1.

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Do More to Capture Nonprescription Drug Use Info: Meeting

Participants in a 4/23 FDA meeting on increasing access to nonprescription drugs see a need to improve the electronic health record capture of information about nonprescription drug use.

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Osfamide Shortage Seen

An oncology physician association says its members are reporting a shortage of the chemotherapy agent ifosfamide for which no direct substitute is available.

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Animal Drugs

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Antimicrobial Animal Drug Finalized Safety Guidance

FDA issues a finalized guidance on evaluating the safety of antimicrobial animal drugs based on their role in human medicine.

medical-devices
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Petition Urges FDA to Restrict Antibiotic Use in Animals

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals for the routine use of...

medical-devices
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FDA Authorizes 1st Generic Animal Drug for New World Screwworm

FDA authorizes Felix Pharmaceuticals’ generic nitenpyram tablets to treat New World screwworm infestations in dogs and cats.

medical-devices
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Open Letter to Trump Urges FDA Push on Rare Diseases

In an opern letter to president Trump, rare disease advocates urge him to push FDA to accelerate approvals for treatments targeting fatal genetic diso...

Biologics

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medical-devices
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FDA Approves First Drug for Warm Autoimmune Hemolytic Anemia

FDA approves a Janssen Biotech BLA for Imaavy (nipocalimab-aahu) injection for warm autoimmune hemolytic anemia in adult and pediatric patients.

medical-devices
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Jemperli sBLA for Rectal Cancer Accepted for Priority Review

FDA accepts for priority review a GSK supplemental BLA for Jemperli (dostarlimab) for certain patients with previously untreated Stage II and III loca...

medical-devices
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HHS Seeks Input on Categories of Federal Vaccine Recommendations

HHS seeks input on how the federal government classifies vaccine recommendations, including whether its current system gives patients and parents enou...

medical-devices
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FDA 3-Month Review Extension on Capricor Gene Therapy

FDA extends by three months its review of a Capricor Therapeutics BLA for Deramiocel, an investigational cell therapy for Duchenne muscular dystrophy ...

FDA General

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medical-devices
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HHS to Appoint 2 New FDA Deputy Commissioners: CNBC

CNBC reports that HHS plans to appoint two new FDA deputy commissioners in hopes of exerting more influence over the agency.

medical-devices
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Webinar on FDA’s Bayesian Draft Guidance

FDA announces a 10/14 Webinar on its recent draft guidance on Use of Bayesian Methodology in Clinical Trials of Drugs and Biologics.

medical-devices
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Commissioner Pick Faces Potentially Lengthy Senate Confirmation

Senate confirmation of FDA commissioner nominee Heidi Overton appears to be getting some resistance and a quick Senate confirmation seems unlikely.

medical-devices
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Trump Picks Health Policy Adviser Overton as FDA Commissioner Nominee

President Donald Trump selects White House health policy adviser Heidi Overton as his nominee to become FDA commissioner.

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Federal Register

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FDA Moves to Cement Complete Response Letter Transparency Policy

FDA looks to formalize one of its most significant transparency initiatives in decades: the public r...

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FDA Warns Brazilian Drug Maker Over Records Request

FDA sends a Warning Letter to Brazilian over-the-counter drug manufacturer Aeroflex Industria de Aer...

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FDA Delays Review Action on Alzheimer’s Drug

FDA delays by three months its decision on Eisai and Biogen's subcutaneous starting-dose formulation...

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Alnylam Pharma’s Web Promo is Misleading: FDA

FDA sends an untitled letter to Alnylam Pharmaceuticals, citing misleading promotional claims on a c...

Human Drugs

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Do More to Capture Nonprescription Drug Use Info: Meeting

Participants in a 4/23 FDA meeting on increasing access to nonprescription drugs see a need to impro...

motusgi
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Osfamide Shortage Seen

An oncology physician association says its members are reporting a shortage of the chemotherapy agen...

motusgi
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Petition Seeks Carbetocin OK for Postpartum Hemorrhage

Two physicians affiliated with Stanford University’s medical school urge FDA to approve carbetocin f...

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Celcuity Files sNDA for Revtorpyk Expanded Use

Celcuity files a supplemental NDA for Revtorpyk (gedatolisib) for treating certain patients with hor...

Marketing

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FDA Plan Would ‘Fundamentally Reshape’ Drug Ads

Two Sheppard attorneys say an FDA proposal to require complete safety and risk information within th...

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FDA Cites Sanofi Over Misleading Beyfortus Promotional Emails

FDA sends an untitled letter to Sanofi Vaccines U.S., alleging that promotional emails for its respi...

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Friendly Accelerated Approval Disclosures Improve Drug Understanding: Study

A new study suggests that direct-to-consumer prescription drug Web sites may better communicate the ...

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DTC Advertising Industry Braces for Potential End of Adequate Provision

DTC Perspectives CEO Bob Ehrlich warns that an upcoming FDA proposal to eliminate the adequate provi...

Medical Devices

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Boston Scientific ENROUTE System Recall is Class 1

FDA says the Boston Scientific recall of its ENROUTE Transcarotid Neuroprotection System is Class 1.

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FDA Issues Alert on Abiomed Impella Controllers

CDRH issues an early alert to notify the public about an Abiomed action recommending that all Automa...

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Wearable Device Monitors Ketone Levels and Blood Sugar

FDA grants Abbott Diabetes Care a de novo authorization for the Libre Duo 10 Day Continuous Dual Glu...

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Early Alert on CooperSurgical Neonatal CPAP Ventilator

FDA issues an early alert about a potentially high-risk problem involving certain CooperSurgical INC...