FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

331 Covid Tests, Sample Collectors Authorized

[ Price : $8.95]

CDRH Office of In Vitro Diagnostics and Radiologic Health director Timothy Stenzel updates the number of authorized Covid-19 tests...

Months for FDA to Warn About Tianeptine: Consumer Reports

[ Price : $8.95]

A Consumer Reports investigative report says FDA showed no urgency in 2018 to take action against a dietary supplement with opioid...

Former FDA Chief of Staff on Biden Covid Team

[ Price : $8.95]

The Biden administration adds former FDA chief of staff Lauren Silvis to its Covid-19 response team.

Aquestive Therapeutics NDA Resubmission Plans

[ Price : $8.95]

Aquestive Therapeutics says that feedback from FDA has put it on a clear path to resubmit its NDA for Libervant (diazepam) Buccal ...

Amondys 45 OKd for Duchennes

[ Price : $8.95]

FDA grants accelerated approval to Sarepta Therapeutics NDA for Amondys 45 (casimersen) injection for treating exon 45 skipping Du...

FDA Labeling Health Claim Enforcement Up Under Biden: Attorneys

[ Price : $8.95]

Three Hogan Lovells attorneys predict an increase in FDA enforcement action against health-related claims in product labeling.

FDA Ambiguous Digital Health Enforcement Discretion

[ Price : $8.95]

Panelists at a virtual digital health conference say FDA enforcement discretion in their arena is ambiguous.

Biden Pivoting on Commissioner Frontrunners

[ Price : $8.95]

The Biden Administration shifts in its consideration of both acting commissioner Janet Woodcock and former FDA principal deputy co...

FDA Allows Pfizer Vaccine Warmer Storage Temp

[ Price : $8.95]

FDA says it is allowing undiluted frozen vials of the Pfizer-BioNTech Covid-19 Vaccine to be transported and stored at conventiona...

Info Collection on Humanitarian Use Devices

[ Price : $8.95]

Federal Register notice: FDA sends to OMB an information collection extension entitled Medical Devices; Humanitarian Use Devices (...