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FDA, Device Industry Reach Agreement on MDUFA VI

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FDA and the device industry are nearing a final agreement on the next round of Medical Device User Fee Act (MDUFA VI) negotiations...

Medline Class 1 Recall of Angiographic Control Syringes

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Medline Industries recalls (Class 1) its angiographic control syringes, warning the devices could cause severe injury or death.

Will the Push for DTC Pre-Review Grow?

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Two Hyman, Phelps & McNamara attorneys describe the impacts on industry if FDA responds to a congressional push for more pre-revie...

RFK Jr. Tones Down Vaccine Skepticism in Run Up to Midterms

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HHS secretary Robert F. Kennedy Jr. curtails his public commentary on vaccines as part of a deliberate political strategy by the T...

Alymsys Patient Brochure False or Misleading: FDA

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The CDER Office of Prescription Drug Promotion says an Amneal patient brochure for its Avastin biosimilar Alymsys is false or misl...

America First Fee Incentives Discussed in PDUFA Meeting

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Minutes of the 3/10 and 3/12 PDUFA 8 reauthorization steering committee sessions, progress was reported on the America First fee i...

Granules Steps Up Oversight at Troubled India Facility

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Granules India Ltd tightens oversight of its manufacturing operations at its largest facility based on FDA-documented compliance i...

Inspection Cites Thermo Fisher Manufacturing Facility

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FDA cites GMP deficiencies at a facility operated by Thermo Fisher Scientific (Patheon Italia unit) in Ferentino, Italy.

FDA Budget Proposal Signals Push for Tighter Ad Oversight

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Law firm Sheppard breaks down some of FDAs proposals in its budget documents that industry should keep a close eye on, including n...

Workshop on Novel Surrogate Endpoints for Rare Disease Drugs

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FDA announces a 5/18 virtual public workshop aimed at advancing the use of novel surrogate endpoints in developing treatments for ...