FDA Related News

Human Drugs

FDA Rejects NDA for Recro Meloxicam

FDA issues a complete response letter to Recro Pharma for its IV meloxicam NDA.

Human Drugs

Pfizer Settles False Claims Case for $23 Million

Pfizer settles a False Claims Act case involving kickbacks for three of its drugs for $23.85 million.

Senate Gives FDA $159 Million Boost, 50% Less Than House

A Senate Appropriations Committee approves $2.97 billion in discretionary funding for FDA, which is $159 million (5%) over the FY 2018 enacted level, ...

Medical Devices

FDA Clears Mauna Kea Cellvizio 100 Neurosurgical Laser

FDA clears a Mauna Kea Technologies 510(k) for the Cellvizio 100 series F400 and F800 multidisciplinary confocal laser endomicroscopy platform for use...

Federal Register

Guide on Anthrax Prevention Drugs

Federal Register notice: FDA makes available a guidance entitled Anthrax: Developing Drugs for Prophylaxis of Inhalational Anthrax.

Federal Register

Comments Sought on Study Design for Heartworm Drugs

Federal Register notice: FDA seeks comments as it evaluates current thinking about the design of studies intended to generate data to support investig...

Federal Register

Info Collection Extension for PDMA Policies, Requirements

Federal Register notice: FDA submits to OMB for approval an information collection extension for Prescription Drug Marketing Act of 1987 Administrati...

Human Drugs

FDA Clears Cotinga Cancer Trial Amendment

FDA clears a protocol amendment to expand the Phase 1b/2a clinical trial of Cotingas COTI-2 to evaluate additional cancers as a combination therapy.

Human Drugs

Pine Pharmaceuticals FDA-483 Released

FDA releases the FDA-483 with three observations from an inspection at Pine Pharmaceuticals.

Human Drugs

MUsT Guidance Helps OTC Studies

CDER director of nonprescription drug products director Theresa Michele says the agency has issued a guidance on maximal usage studies to help OTC dru...