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Human Drugs

FDA Postpones Meeting on OTC Birth Control Pill

FDA postpones an 11/18 joint advisory committee that was going to vote on a Laboratoire HRA Pharma supplemental NDA for Opill (norgestrel, 0.075 mg), ...

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Human Drugs

Priority Review for Seres BLA for c.diff Therapy

FDA accepts for priority review a Seres Therapeutics BLA for its investigational oral microbiome therapeutic SER-109 for preventing recurrent C. diffi...

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Federal Register

Workshop on PET Imaging in Alzheimers Patients

Federal Register notice: FDA announces an 11/17 public workshop entitled Quantitative Brain Amyloid PET Imaging in Patients with Alzheimers Disease....

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Human Drugs

ICH Presentation on Selective Safety Data Collection

The International Council for Harmonization posts a presentation outlining its finalized guidance entitled A Selective Approach to Safety Data Collect...

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Human Drugs

Positive Results in AZ Breast Cancer Trials

AstraZeneca reports positive results from two trials evaluating new breast cancer treatments.

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Federal Register

Rare Disease Endpoint Pilot Program

Federal Register notice: FDA launches a Rare Disease Endpoint Advancement Pilot Meeting Program.

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Human Drugs

CGMP Violations at Nephron SC

FDA warns West Columbia, SC-based Nephron SC about CGMP and other violations at its drug manufacturing facility.

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Human Drugs

Panel Reviewing Ipsen NDA Postponed

FDA says it is postponing a 10/31 Endocrinologic and Metabolic Drugs Advisory Committee meeting that was scheduled to review and vote on an Ipsen Biop...

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Human Drugs

CGMP, Other Violations at Advanced Cosmetic Lab

FDA warns Chatsworth, CA-based Advanced Cosmetic Research Laboratories about CGMP violations and marketing of misbranded unapproved new drugs.

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Human Drugs

Jubilant Generics FDA-483

FDA releases the form FDA-483 with six observations from an inspection at Indias Jubilant Generics.