FDA Related News

Federal Register

Comments Sought on Biologic Adverse Event Reporting

Federal Register notice: FDA seeks comments on an information collection extension for Adverse Experience Reporting for Licensed Biological Products; ...

Federal Register

Comments Sought on Combination Product Guidance

Federal Register notice: FDA seeks comments on a new information collection related to a Draft Guidance for Industry How To Prepare a Pre-Request for...

DoJ Views on Responsible Executive Prosecutions

Attorney Michael Blume says Justice Department briefs in the DeCoster Quality Egg case appeals give valuable insights into how it will prosecute corpo...

Human Drugs

FDA Approves Pumas Nerlynx for Breast Cancer

FDA approves a Puma Biotechnology NDA for Nerlynx (neratinib) for the extended adjuvant treatment of early-stage, HER2-positive breast cancer.

Human Drugs

Priority Review for Spark Gene Therapy BLA

FDA accepts for priority review a Spark Therapeutics BLA for Luxturna (voretigene neparvovec), a investigational gene therapy for treating patients wi...

Human Drugs

FDA Researching Fair Balance with DTC Tweets, Etc.

FDA proposes new research to be conducted on prescription drug promotional messages that are embedded in character space-limited online prescription d...

Human Drugs

FDA REMS Standards Need Assessment

FDA posts a REMS Platform Standards Initiative: Needs Assessment document that is intended to help standardize risk evaluation and mitigation strategi...

FDA General

Gottlieb Moves to Overcome Hundreds of Scientific Vacancies

FDA commissioner Scott Gottlieb orders a comprehensive review of the agencys hiring practices and procedures in order to speed up processes to bring n...

Human Drugs

Complete Response Letter on Amgen Bone Drug

FDA issues Amgen a Complete Response Letter on its BLA for the Evenity (romosozumab) as a treatment for postmenopausal women with osteoporosis.

Repros Proellex Remains on Hold Over Liver Safety Data

FDA tells Repros Therapeutics that its clinical development program for Proellex, an oral delivery mechanism for telapristone acetate for treating ute...