FDA Related News

Human Drugs

Ex-CDER Official Laughren Retained by PharmaTher

PharmaTher Holdings retains former CDER antipsychotic guru Thomas Laughren as a regulatory affairs advisor to help a depression therapy.

Human Drugs

FDA Approves AbbVies Qulipta for Migraine Prevention

FDA approves AbbVies novel migraine prevention drug Qulipta.

Safety Reporting Investigator Responsibility Guidance

FDA publishes a draft guidance on investigator responsibilities for safety reporting for INDs and IDEs.

Human Drugs

Guidance on Microbiological Quality in Non-Sterile Drugs

FDA publishes a draft guidance on microbiological quality control of non-sterile drugs.

Federal Register

Tropical Disease Review Voucher Fee Rate

Federal Register notice: FDA announces the fee rates for using a tropical disease priority review voucher for fiscal year 2022 $1,266,651.

Federal Register

Rare Pediatric Disease Priority Voucher Fee

Federal Register notice: FDA announces the fee rate for using a rare pediatric disease priority review voucher for fiscal year 2022 $1,266,651.

Federal Register

Fee Rate for Medical Countermeasure Voucher

Federal Register notice: FDA sets the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2022 $1,266...

Human Drugs

Drug, Biologicals Benefit/Risk Assessment Guidance

FDA publishes a guidance on benefit/risk assessment in NDAs and BLAs.

FDA General

3 Ex-FDA Lawyers Join Sidley

Sidley says three former FDA attorneys have joined its Global Healthcare and FDA practice.

Human Drugs

Use Data-Driven Approach to Drug Analysis: Researchers

University of Chicago researchers say FDA should use a more data-driven approach to postmarket drug surveillance to avoid falsely determining that a d...