FDA Related News

Type 5 DMFs for Drug-led Combo Product Guide

FDA posts a draft guidance on Type V DMFs for CDER-Led Combination Products Using Device Constituent Parts with Electronics or Software.

Human Drugs

FDA Fact Sheet on Device Consensus Standards Pilot

FDA releases a fact sheet to explain its Accreditation Scheme For Conformity Assessment (ASCA) Pilot Program: Draft Guidance.

Federal Register

Info Collection Extension for CLIA Categorizations

Federal Register notice: FDA sends to OMB an information collection extension entitled Administrative Procedures for Clinical Laboratory Improvement A...

Human Drugs

Allergan Pays $750 Million on Namenda Switch Scheme

Allergan and its Forest Laboratories subsidiaries agree to pay $750 million to settle a lawsuit brought by direct purchasers of Alzheimer drug Namenda...

Human Drugs

Heron NDA Resubmission for Post-Op Pain Drug

FDA accepts for review a Heron Therapeutics NDA resubmission for HTX-011, an investigational agent for managing postoperative pain.

Federal Register

Latest Federal Register Notices

FDA Review posts the Federal Register notices for the week ending 10/25/2019.

FDA General

Since Our Last Issue ...

Industry news you may have missed since our last issue.

Federal Register

Orthopedic Surgical Instruments Put Into Class 2

Federal Register notice: FDA classifies orthopedic surgical instrumentation designed for osteochondral implants with press-fit fixation into Class 2 (...

Federal Register

Draft Guide on Homeopathic Drug Products

Federal Register notice: FDA makes available a revised draft guidance entitled Drug Products Labeled as Homeopathic.

Federal Register

Allergan NDA Lo Minastrin FE Withdrawn

Federal Register notice: FDA withdraws the NDA approval of Allergan Pharmaceuticals Lo Minastrin FE because it is no longer marketed.