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Panel to Discuss Pulse Generators

[ Price : $8.95]

Federal Register Notice: FDAs Circulatory System Devices Panel will meet 10/8-9 to discuss CRT-P and CRT-D devices and a CardioMEM...

Altaire Pharma Recalls Eye Drops

[ Price : $8.95]

Altaire Pharmaceuticals recalls nine lots of carboxymethylcellulose sodium 0.5% ophthalmic solution, 30 mL, due to mold complaints...

FDA Review Documents Favor Glaxos COPD Drug

[ Price : $8.95]

FDA reviewers say clinically meaningful efficacy data have been submitted by GlaxoSmithKline to support an NDA for combination ume...

McNeil Recalls 3 Lots of Motrin Infant Drops

[ Price : $8.95]

McNeil Consumer Healthcare recalls three lots of concentrated Motrin Infants Drops Original Berry Flavor 1/2 fl oz bottles after p...

FDA Infectious Disease Status for Cempra Antibiotic

[ Price : $8.95]

FDA issues Cempra a Qualified Infectious Disease Product designation for oral solithromycin (CEM-101), indicated for treating comm...

FDA Submits Info on Authorized Generics to OMB

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Federal Register Notice: FDA submits a proposed collection of information on reporting information for authorized generic drugs.

Medaus Pharmacy Recalls Sterile Drugs

[ Price : $8.95]

Medaus Pharmacy recalls certain sterile compounded consumer products due to its inability to confirm that quality control testing ...

FDA Meeting with QRxPharma on Rejected Moxduo

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FDA schedules a 10/3 end-of-review meeting with QRxPharma to discuss the companys NDA for Moxduo, which resulted in a complete res...

Hamburg Forms Senior Group to Modify FDA Functions

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FDA commissioner Margaret Hamburg forms an internal Program Alignment Group (PAG) made up of senior agency staff to identify and d...

Guidance on UFI for Drug Establishment Registration

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Federal Register Notice: FDA releases a draft guidance: Specification of the Unique Facility Identifier (UFI) System for Drug Esta...