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FDA General

Califf Vows War on Social Media Rx Promos

FDA commissioner nominee Robert Califf says, if confirmed, he is going to be very aggressive on curbing social media medical misinformation.

Federal Register

Oncologic Panel to Review Lung Cancer Therapy

Federal Register notice: FDA announces a 2/10/2022 Oncologic Drugs Advisory Committee meeting that will vote on an Innovent Biologics BLA for sintilim...

Federal Register

FDA Withdraws 6 No-Longer-Marketed ANDAs

Federal Register notice: FDA withdraws approval of six ANDAs from multiple applicants after they notified the agency that the products were no longer ...

Federal Register

Info Collection on Expanded Access

Federal Register notice: FDA seeks comments on an information collection revision entitled Expanded Access to Investigational Drugs for Treatment Use....

Human Drugs

Pfizer Covid Oral Drug 89% Effective

Pfizer says new data on its Covid-19 oral antiviral drug Paxlovid (nirmatrelvir tablets and ritonavir tablets) show the drug significantly reduced the...

Biologics

Significant HCT/P Deviations at Cooper Institute

FDA warns Houstons Cooper Institute for Advanced Reproductive Medicine about significant deviations from the regulations for human cells, tissues, and...

Human Drugs

Covid-19 Actemra REMS Guidance

FDA issues a guidance modifying REMS requirements for Genentechs Actemra under certain conditions during the Covid-19-related Actemra shortage.

Medical Devices

FDA Approves 2 Svelte Stent Systems

FDA approves two Svelte Medical drug-eluting stent systems.

Federal Register

Draft Guide on Bowel Cleansing Products

Federal Register notice: FDA makes available a draft guidance entitled Bowel Cleansing for Colonoscopy: Efficacy and Safety Considerations for Develop...

Federal Register

Pediatric Anti-infective Drug Guidance

Federal Register notice: FDA makes available a final guidance entitled Development of Anti-Infective Drug Products for the Pediatric Population.