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5 FDA Areas of Likely Emphasis in Biden Administration

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Three Covington & Burling attorneys identify five areas of FDA work where the Biden administration may exercise priorities.

FDA Support for U.S.-Mexico-Canada Trade Agreement

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FDA senior trade advisors outline reasons why the new U.S.-Mexico-Canada agreement is better for the agency and public health than...

Guide on Contraceptive Drug Interaction Studies

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Federal Register notice: FDA makes available a draft guidance entitled Clinical Drug Interaction Studies With Combined Oral Contra...

Animal Drug Impurities Q&A Guidance

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

HHS Moves to Terminate FDA Unapproved Drugs Initiative

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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

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

Orphan Drug Designation Portal Launched

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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

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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

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