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

latest-news

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

LATEST NEWS

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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 enough choice.

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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 (DMD).

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Study Finds Severe Liver Injury in Small Number of Avacopan Patients

As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study finds that while liver enzyme elevations were uncommon among patients treated with avacopan, although two cases of drug-induced liver injury were identified.

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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 INCA neonatal and infant nasal continuous positive airway pressure sets.

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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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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
Read More
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 ...

medical-devices
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CBER Updates Process for Formal Disputes With Sponsors

CBER updates its standard operating procedures for resolving scientific/procedural disputes between sponsors and the Center, establishing revised proc...

medical-devices
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Cellular, Gene Therapy Product FAQs

FDA publishes a guidance with frequently asked questions on the development of cellular and gene therapy products.

FDA General

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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.

medical-devices
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Trump Administration Weighs Executive Order on Autism, Vaccines

The Trump administration considers an executive order addressing vaccines and autism as soon as next week.

medical-devices
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FDA Posts User Fee Rates for FY 2027

FDA posts the following user fee rates for medical product programs for fiscal year 2027.

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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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Study Finds Severe Liver Injury in Small Number of Avacopan Patients

As Amgen continues its bid to prevent the withdrawal of Tavneos (avacopan) in the U.S., a new study ...

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Scholar Rock Removes Catalent Facility from BLA to Advance Apitegromab

Scholar Rock says it has made further regulatory progress for apitegromab, its investigational treat...

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Lawmakers Urge FDA to Up Scrutiny of Clinical Data From China

House Select Committee on China chairman John Moolenaar (R-MI) and Rep. Ben Cline (R-VA) are urging ...

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FDA Issues New Guidance on Therapeutic Equivalence Evaluations

FDA issues a final guidance describing how it evaluates therapeutic equivalence among prescription d...

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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Early Alert on CooperSurgical Neonatal CPAP Ventilator

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

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Boston Scientific Recalls ENROUTE Percutaneous Catheter Kit

Boston Scientific recalls its ENROUTE Transcarotid Neuroprotection System Plus, a single-use percuta...

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Early Alert on : GE HealthCare Portrait Core Monitor Software

CDRH issues an Early Alert after becoming aware that GE HealthCare sent a letter alerting affected c...

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Digital Health Technologies Capture Real-Time Info: Column

FDA Digital Health Center of Excellence director Rick Abramson outlines an agency white paper on dev...