FDA Related News

FDA Activities to Expand Real-World Evidence Use

FDA commissioner Scott Gottlieb outlines ways the agency hopes to expand use of real-world data and real-world evidence.

Human Drugs

CGMP Violations at Hangzhou Guoguang Touring Commodity

FDA warns Chinas Hangzhou Guoguang Touring Commodity Co. about CGMP violations in producing finished pharmaceuticals as a contract manufacturer.

Ad Price Disclosure Ill-Conceived, Illegal: WLF

Attorney Howard Dorfman says the CMS proposal to require companies to include the prescription drug wholesale acquisition price in DTC ads is ill-conc...

Human Drugs

NDA/ANDA User Fee Acceptance Dates for Shutdown Filings

An FDA notice outlines NDA/BLA/ANDA user fee acceptance dates for submissions received during the partial government shutdown.

Medical Devices

MediPines Gas Exchange Monitor Cleared

FDA clears a MediPines 510(k) for the MediPines Gas Exchange Monitor, which is intended for real-time pulmonary parameters and insights to support rap...

Human Drugs

Doctors Concerns About FDA Approvals, Off-Label Marketing

Researchers say most doctors surveys are concerned about FDA accelerated drug approvals and dont like eased restrictions on off-label marketing.

FDA General

Latest FDA Warning Letters

FDA releases its latest batch of Warning Letters that include Hangzhou Guoguang Touring Commodity Co. and University of Miami Reproductive and Fertili...

Human Drugs

Drug Product Electronic Application Submission Guidance

FDA issues a guidance extending the implementation date for electronic format submissions of Type 3 drug master files.

FDA General

FDA Not Consistent with Common Rule: Attorneys

Morgan Lewis attorneys say FDA promises to write rules in the future to better align its human subject protection regulations with the new federal Com...

Human Drugs

FDA OKs I-Mab Biopharma IND for Cancer Immunotherapy

FDA approves an I-Mab Biopharma IND for TJC4, a human anti-CD47 monoclonal antibody for cancer immunotherapy.