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Medical Devices

Coronavirus Test Goal Wont be Met: Pence

Vice president Mike Pence admits that the government will not meet its projected goal of delivering one million coronavirus tests throughout the U.S. ...

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FDA publishes a draft guidance on including older adults in oncology clinical trials.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Federal Register notice: FDA makes available a draft guidance entitled Soft (Hydrophilic) Daily Wear Contact Lenses Performance Criteria for Safety a...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...