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List of Difficult Drugs for Compounding

[ Price : $8.95]

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

Device Software Precertification Pilot Program

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

Public Meeting on Real World Evidence Challenges

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

FDA Safety Alert on Compounded Eye Drops

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FDA issues a safety alert after it received recent adverse event reports about Guardian Pharmacy Services compounded triamicinolon...

Advanced Accelerator Applications Re-files NDA

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Advanced Accelerator Applications resubmits an NDA for Lutathera (lutetium Lu 177 dotatate) for treating unresectable or metastati...

Injunction Entered Against Crown Laboratories

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A Tennessee federal court enters a permanent injunction stopping Crown Laboratories from distributing unapproved and misbranded dr...

AZ, Merck Working Together on Lynparza

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

Aradigm Files NDA for Pulmonary Drug Linhaliq

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Aradigm files an NDA for Linhaliq (liposomal ciprofloxacin for inhalation) for treating non-cystic fibrosis bronchiectasis patient...

Assayed Quality Control Material Placed Into Class 2

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

Class 2 Status for Balloon Aortic Valvuloplasty Catheter

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