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Draft Guide on Coordinated Antimicrobial Drug/Test Development

[ Price : $8.95]

Federal Register Notice: FDA announces the availability of a draft guidance entitled Coordinated Development of Antimicrobial Drug...

Guidance on Reporting Device Studies on Computational Modeling

[ Price : $8.95]

Federal Register Notice: FDA releases a guidance entitled Reporting of Computational Modeling Studies in Medical Device Submission...

FDA Posts Revised Listing of Device Consensus Standards

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Federal Register Notice: FDA announces a publication containing modifications to the agencys list of standards it recognizes for u...

Janssens Invokamet Approved for New Indication

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FDA approves a Janssen Pharmaceuticals supplemental NDA for Invokamet XR (canagliflozin and metformin hydrochloride) for first-lin...

Groups Fear Weakened REMS

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The 16 member organizations of the Patients Alliance for Drug Safety Protections caution that proposed legislation could weaken FD...

Armenpharm ANDA Withdrawn for Safety/Effectiveness

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Federal Register Notice: FDA suspends approval of an Armenpharm, Ltd. ANDA for chloramphenicol capsules, 250 mg because previous v...

False Advertising Claim Not Precluded by FFDCA

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The 2nd Circuit Appeals Court says that the fact that FDA cleared a home pregnancy test with specific instructions on how it is to...

Heidelberg Engineering 510(k) Clearance for Glaucoma Module

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FDA clears a Heidelberg Engineering 510(k) to market its Spectralis OCT Glaucoma Module Premium Edition that is intended to provid...

FDA Accepts TherapeuticsMD NDA for Yuvvexy

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FDA accepts for review a TherapeuticsMD NDA for Yuvvexy, an investigational bio-identical 17β-estradiol vaginal softgel capsu...

FDA Draft Guide on Determining When REMS is Necessary

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FDA posts a draft guidance on FDAs Application of Statutory Factors in Determining When a REMS Is Necessary.