FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Evaluate Generic Bicalutamide Manufacturers: Petition

[ Price : $8.95]

A Buchanan petition on behalf of an interested client asks FDA to take specified actions to determine whether there is a patient s...

Agency Seeks Updated Generic Accutane Labels

[ Price : $8.95]

FDA asks manufacturers of generic Accutane to update the drugs labeling.

FDA Backs Accelerated Pathway for UniQure Huntington's Therapy

[ Price : $8.95]

FDA tells UniQure that data from its ongoing Phase I/II study of AMT-130 could serve as the primary basis for a BLA seeking accele...

FDA, African Medicines Agency Agreement on Regulatory Harmonization

[ Price : $8.95]

FDA and the African Medicines Agency sign a Statement of Cooperation establishing a formal framework for collaboration between the...

FDA Accepts Outlook Therapeutics' Resubmitted BLA for Lytenava

[ Price : $8.95]

FDA accepts for review a BLA resubmission from Outlook Therapeutics seeking approval of ONS-5010/Lytenava (bevacizumab-vikg) for t...

Leadership Changes Affect FDA Priorities: Mintz Post

[ Price : $8.95]

Two Mintz attorneys examine what has happened to some of former FDA commissioner Marty Makarys initiatives following his resignati...

Petition Urges FDA to Restrict Antibiotic Use in Animals

[ Price : $8.95]

A coalition of 65 health, environmental, consumer, farming, and animal welfare organizations petition FDA to withdraw approvals fo...

Panel to Weigh Favorable Data on Moderna's mRNA Flu Vaccine

[ Price : $8.95]

A 6/18 advisory committee meeting is set to review Moderna's investigational mRNA influenza vaccine as the agency posts a briefing...

FDA Delays Isotretinoin REMS Modifications

[ Price : $8.95]

FDA says there is an implementation delay for isotretinoin iPLEDGE Risk Evaluation and Mitigation Strategy modif...

Zoll Medical QSR, MDR Violations

[ Price : $8.95]

FDA warns Chelmsford, ME-based Zoll Medical about Quality System and Medical Device Reporting violations in its manufacturing of s...