FDA Related News

Medical Devices

Another UDI Extension for Soft Contact Lens Labelers

FDA grants an extension for soft contact lens labelers to comply with the requirements of the Unique Device Identification system.

Biologics

FDA Sets Panel Meeting for Dynavax Resubmission

FDA tells Dynavax Technologies that the Vaccines and Related Biological Products Advisory Committee will review 7/28 the companys BLA for Heplisav-B [...

Medical Devices

ETS Wound Care Device Cleared

FDA clears an ETS Wound Care 510(k) for the Mirragen Advanced Wound Matrix for use in treating acute and chronic wounds.

Human Drugs

FDA Approves Tevas Huntingtons Disease Drug

FDA approves a Teva Pharmaceutical Industries NDA for Austedo (deutetrabenazine) tablets for treating chorea associated with Huntingtons disease.

Warning Letters Focus on Document Control, Data Integrity

Recent Warning Letters show that document control and data integrity remain key concerns of FDA investigators, according to an analysis by AssurX.

Human Drugs

Latest Federal Register Notices

FDA Review posts Federal Register notices for the week ending 3/31/2017.

FDA General

FDA to Win or Lose $40 mil. in Continuing Resolution: Alliance

Alliance for a Stronger FDA says the agency could win or lose $40 million in the current fiscal year continuing resolution depending on whether Congre...

Human Drugs

FDA Full Approval for Tagrisso in Lung Cancer

FDA grants full approved to an AstraZeneca NDA for Tagrisso (osimertinib) 80mg once-daily tablets for treating patients with metastatic epidermal grow...

Human Drugs

Pfizer Gains Regular Approval, Expanded Use for Ibrance

FDA approves a Pfizer supplemental NDA for Ibrance (palbociclib) that converts the previous accelerated approval to a regular approval based on the re...

Human Drugs

FDA Priority Review for Novartis CAR-T Therapy

FDA accepts for priority review a Novartis BLA for CTL019 (tisagenlecleucel-T), an investigational chimeric antigen receptor T cell therapy, for use i...