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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

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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.

Latest Federal Register Notices

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FDA Review posts the Federal Register notices for the week ending 11/20/2020.

Guide on Biosimilarity and Interchangeability

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Federal Register notice: FDA makes available a draft guidance entitled Biosimilarity and Interchangeability: Additional Draft Q&As...

Cross Labeling Oncology Drugs Guidance

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Federal Register notice: FDA announces the availability of a draft guidance for industry entitled Cross Labeling Oncology Drugs in...

J&J Subsidiary Pays $10 Million on Drug/Device Promo Violations

[ Price : $8.95]

Johnson & Johnson subsidiary Medical Device Business Services agrees to pay $10 million to settle allegations under the False Clai...

Covid-19 Device EUA Listing Updated

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Federal Register notice: FDA updates its ongoing listing of issued and reissued Emergency Use Authorizations for medical devices r...