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ReVision Optics Files PMA Module for Vision Inlay

[ Price : $8.95]

ReVision Optics files its fourth and final PMA module for the Raindrop Near Vision Inlay, a microscopic hydrogel inlay designed to...

FDA Guidance on Generic Drug Controlled Correspondence

[ Price : $8.95]

FDA issues a final guidance on Controlled Correspondence Related to Generic Drug Development that gives advice on the process for ...

Meeting on Estrogen Product Labeling

[ Price : $8.95]

Federal Register Notice: FDA plans a public meeting 11/10 on the labeling for lower-dose vaginal estrogen products intended to tre...

Meeting on Biosimilar User Fee Act

[ Price : $8.95]

Federal Register Notice: FDA plans a public meeting 12/18 on the reauthorization of the Biosimilar User Fee Act for fiscal years 2...

Safety Alert on Proper Cranial Perforator Use

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FDA issues a safety alert to remind neurosurgeons about the techniques for the safe use of cranial perforators with an automatic c...

FDA Rejects Cephalon Petition on Treanda ANDAs

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FDA declines without comment a Cephalon petition that urged the agency to not approve an ANDA that references its Treanda (bendamu...

Ex-Novartis R&D Specialist to Lead CDER Quality Office

[ Price : $8.95]

FDA chooses former Novartis global research and development vice president Michael Kopcha as CDER Office of Pharmaceutical Quality...

ICH Revision to Good Clinical Practice Guideline

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FDA posts an International Conference on Harmonization draft guideline that revises E6 (R1): Guideline For Good Clinical Practice ...

FDA Sets Fee Rate for Rare Pediatric Disease Vouchers

[ Price : $8.95]

Federal Register Notice: FDA announces the fee rate for using a rare pediatric disease priority review voucher for fiscal year 201...

ICH Guidance on Mutagenic Impurities in Pharmaceuticals

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Federal Register Notice: FDA releases an ICH draft guidance: M7(R1) Addendum to ICH M7: Assessment and Control of DNA Reactive (Mu...