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Human Drugs

Cancer Trial Inclusion Guidance

FDA publishes a draft guidance on including older adults in oncology clinical trials.

Medical Devices

FDA Bans Some Electrical Stimulation Devices

FDA publishes a final rule banning electrical stimulation devices for self-injurious or aggressive behavior.

Human Drugs

Deemed to be a License Questions, Answers

FDA publishes a question-and-answer guidance on the transition provision of the Biologics Price Competition and Innovation Act under which application...

Federal Register

Info Collection on GMPs for Medicated Feeds

Federal Register notice: FDA seeks comments on an information collection extension for medicated feed GMPs.

Federal Register

Regulatory Review Period for Kyowa Asthma Drug

Federal Register notice: FDA determines the regulatory review period for patent extension purposes for Kyowa Hakko Kirins Fasenra (benralizumab).

Federal Register

Guide on Contacts Performance Criteria

Federal Register notice: FDA makes available a draft guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety a...

Human Drugs

Recall NDMA-Contaminated Metformin: Valisure

Online pharmacy and testing laboratory Valisure says it has detected NDMA contamination in some lots of metformin from several companies.

Human Drugs

Median Drug Development Cost is $985 Million: Study

Researchers say the median cost for developing a new drug between 2009 and 2018 was $985 million.

Human Drugs

Mallinckrodt Sued Over Rebate Issue After New Indication

The U.S. government files a False Claims Act suit against Mallinckrodt ARD (previously Questcor Pharmaceuticals) for allegedly underpaying Medicaid re...

Human Drugs

FDA Requires Singulair Boxed Warning

FDA orders a Boxed Warning to be added to labeling for Mercks Singulair and its generic forms on the risk of neuropsychiatric events.