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Federal Register

List of Difficult Drugs for Compounding

Federal Register notice: FDA develops a list of drug products and categories of drug products that are difficult to compound.

Federal Register

Device Software Precertification Pilot Program

Federal Register notice: CDRH announces a Software Precertification Pilot Program to evaluate a new approach for software products, including a precer...

Human Drugs

Public Meeting on Real World Evidence Challenges

FDA announces a 9/13 public workshop on Developing a Framework for Regulatory Use of Real-World Evidence.

Human Drugs

FDA Safety Alert on Compounded Eye Drops

FDA issues a safety alert after it received recent adverse event reports about Guardian Pharmacy Services compounded triamicinolone and moxifloxacin p...

Human Drugs

Advanced Accelerator Applications Re-files NDA

Advanced Accelerator Applications resubmits an NDA for Lutathera (lutetium Lu 177 dotatate) for treating unresectable or metastatic, progressive, well...

Human Drugs

Assayed Quality Control Material Placed Into Class 2

Federal Register notice: FDA classifies the assayed quality control material for clinical microbiology assays into Class II (special controls).

Federal Register

Class 2 Status for Balloon Aortic Valvuloplasty Catheter

Federal Register notice: FDA classifies the balloon aortic valvuloplasty catheter into Class 2 (special controls).

Human Drugs

Hi-Tech Files DMAA Appeal

Hi-Tech Pharmaceuticals asks the 11th Circuit Court of Appeals to rule that its synthetic DMAA, an amphetamine derivative, is a legitimate dietary sup...

Medical Devices

FDA Clears Quantel Easyret Eye Laser

FDA approves a Quantel Medical PMA for the Easyret fully integrated 577nm yellow photocoagulator, indicated for use to treat certain forms of macular ...

Human Drugs

AZ, Merck Working Together on Lynparza

AstraZeneca and Merck announce a collaboration to develop and commercialize AstraZenecas cancer drug Lynparza.