FDA Webview
X
about-us-banner

Pay Per View

Home / Pay Per View

Animal Drug Impurities Q&A Guidance

[ Price : $8.95]

Federal Register notice: FDA makes available a final guidance on elemental impurities in animal drug products.

HHS Moves to Terminate FDA Unapproved Drugs Initiative

[ Price : $8.95]

HHS moves to terminate FDAs unapproved drug initiative as part of Trump administration efforts to reduce prescription drug costs.

AstraZeneca Vaccine Ready for EUA Submission

[ Price : $8.95]

AstraZeneca says it is preparing an emergency use authorization request for its investigational Covid-19 vaccine AZD1222 after rep...

Orphan Drug Designation Portal Launched

[ Price : $8.95]

FDA launches its Orphan Drug Designation Portal to support therapy development for rare diseases by enhancing sponsor communicatio...

Patient Engagement Panel Transcript Available

[ Price : $8.95]

FDA posts a transcript of its 10/22 Patient Engagement Advisory Committee meeting called to discuss and make recommendations on ar...

Expanded Approval for Genentech Flu Drug

[ Price : $8.95]

FDA gives expanded approval to Genentech for Xofluza (baloxavir marboxil) to include post-exposure prevention of influenza for pat...

Kiniksa sBLA for Rilonacept in Recurrent Pericarditis

[ Price : $8.95]

FDA accepts for priority review a Kiniksa Pharmaceuticals supplemental BLA for rilonacept in recurrent pericarditis.

Since Our Last Issue ...

[ Price : $8.95]

Industry news you may have missed since our last issue.

Guide on Biosimilarity and Interchangeability

[ Price : $8.95]

Federal Register notice: FDA makes available a draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As...

Cross Labeling Oncology Drugs Guidance

[ Price : $8.95]

Federal Register notice: FDA announces the availability of a draft guidance for industry entitled Cross Labeling Oncology Drugs in...