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FDA General

Looking at the FDA/Industry Revolving Door

A Grid news report uses Linkedin data to estimate how many former FDAers are now working in regulated companies and discusses the ethical issues raise...

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Human Drugs

Alnylam Pharmaceuticals Plans NDA for Patisiran

Alnylam Pharmaceuticals plans to file an NDA submission late this year for patisiran, indicated for treating transthyretin-mediated amyloidosis with c...

Federal Register

Panel To Review Amylyx ALS Drug

Federal Register notice: FDA announces a 9/7 Peripheral and Central Nervous System Drugs Advisory Committee meeting that will review Amylyx Pharmaceut...

Medical Devices

Glaukos 510(k) Cleared for Intraocular Pressure

FDA clears a Glaukos 510(k) for its iStent Infinite Trabecular Micro-Bypass System and its use in a standalone procedure to reduce elevated intraocula...

Medical Devices

False Claims Liability for Medical Device Off-Label Use

Attorney Keeley McCarty says a recent government suit against Promothesus Group demonstrates the government is willing to use the False Claims Act to ...

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Human Drugs

CGMP and Other Violations at DSP Skin Care

FDA warns Los Angeles, CA-based DSP Skin Care about CGMP and other violations, some repeated from 2018, in its manufacturing of finished drugs.

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Human Drugs

Allarity Refocuses in Response to FDA Comments

Allarity Therapeutics says it is no longer economically feasible to pursue its dovitinib as a monotherapy for some renal cancers and it is refocusing ...

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Human Drugs

IND-Exempt BA/BE Study Guidance

FDA publishes a draft guidance on the electronic submission of expedited individual case safety reports from IND-exempt BA/BE studies through the adve...

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Federal Register

Guide on N-Acetyl-L-Cysteine Enforcement Discretion

Federal Register notice: FDA makes available a final guidance entitled Policy Regarding N-acetyl-L-cysteine.

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Federal Register

Regulatory Review Period for Rozlytrek

Federal Register notice: FDA determines for patent extension purposes the regulatory review period for Genentechs Rozlytrek tablets (entrectinib).