FDA Related News

Human Drugs

Workshop on Drug Analysis Data Standards Advancement

Federal Register notice: FDA announces a 6/12 public workshop entitled Advancing the Development and Implementation of Analysis Data Standards: Key Ch...

Human Drugs

No Benefit in Taking Supplements: NIH Study

NIH director Francis Collins says a study found that dietary supplements do not extend life for most people in the general population.

Biologics

FDA Approved 2 Gene Therapies, 3 Vaccines in 2018: CBER

CBER director Peter Marks posts an FY 2018 annual report highlighting Center accomplishments including approval of two gene therapies and three vaccin...

Human Drugs

Too Many Cancer Immunotherapeutics Available?

FDA Oncology Center of Excellence director Richard Pazdur quizzes cancer immunotherapeutics makers on whether there are too many of their products on ...

Medical Devices

Breakthrough Status for Preeclampsia Targeted Apheresis

FDA grants Advanced Prenatal Therapeutics a breakthrough device designation for its Targeted Apheresis Column for Preeclampsia.

Human Drugs

Intensity Therapeutics Fast Track for Breast Cancer Therapy

FDA grants Intensity Therapeutics a fast track designation for INT230-6 and its use in treating patients with relapsed or metastatic triple negative b...

Human Drugs

FDA Withdraws Approval of 31 ANDAs

Federal Register notice: FDA announces the withdrawal of 31 ANDAs from multiple applicants because they are no longer marketed.

Human Drugs

Hi-Tech Says FDA Warning Letter is Bullying

Hi-Tech Pharmaceuticals accuses FDA of bullying it into withdrawing its dietary supplements containing DMHA.

PhRMA Ad Cost Info Varies: Analysis

Biopharmadive says PhRMA members are responding in varying ways to the associations call for voluntary inclusion of some drug cost information in dire...

Medical Devices

FDA Working to Harmonize Device Quality Regs: Consultants

Medical device consultants Cognition describes efforts by FDA to harmonize design control regulations with a new ISO medical device quality management...