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Human Drugs

Phoenix Biotechnology Marketing Unapproved Covid Drug: FDA

FDA warns Phoenix Biotechnology and Avila Herbals the Oleander 4X homeopathic drug they are marketing to address serious conditions such as Covid-19 i...

Medical Devices

FDA 2020 Device Law and Policy Activities Analyzed

Two Mintz attorneys review FDA medical device regulation and policy in 2020.

Human Drugs

Change OTC Acetaminophen Childrens Dosage Schedule: Petition

Parenteral Technologies asks FDA to amend the dosing schedule for single-ingredient acetaminophen for use in children ages 2-4.

Medical Devices

Penumbra Recalls JET 7 Reperfusion Catheter

Penumbra recalls all configurations of the Penumbra JET 7 Reperfusion Catheter with Xtra Flex Technology due to a risk of unexpected death or serious ...

Human Drugs

FDA Warns Against Some Online Male Products

FDA cautions consumers not to use some male enhancement and weight loss products sold through Amazon and eBay.

Federal Register

Guidance on Drug Complex Innovative Trial Designs

Federal Register notice: FDA posts a final guidance on interacting with the agency about drug complex innovative trial designs.

Human Drugs

FDA Approves MacroGenics Margenza

FDA approves MicroGenics Margenza for some HER2-positive metastatic breast cancers.

Human Drugs

Takeda NDA for Eosinophilic Esophagitis Drug Accepted

FDA accepts for priority review a Takeda Pharmaceutical NDA for Eohilia (budesonide oral suspension) for treating eosinophilic esophagitis.

Biologics

Professors Say Too Few Reviewers on Pfizer Covid Vaccine

Two university professors question FDAs decision to assign only one reviewer to several core scientific areas in the Pfizer Covid-19 vaccine review.

Biologics

Vaccine Panel Recommends EUA for Moderna Covid Vaccine

An FDA advisory committee votes to recommend an Emergency Use Authorization for Modernas investigational Covid-19 vaccine (mRNA-1273).