FDA Related News

Human Drugs

Draft Guide on Pulmonary Tuberculosis Drugs

FDA posts a draft guidance entitled Pulmonary Tuberculosis (TB): Developing Drugs for Treatment.

Draft Inspection Refusal Guidance

FDA publishes a draft guidance defining the types of behaviors that FDA considers to be delaying, denying, or limiting an inspection, or refusing to p...

Biologics

FDA Stem Cell Therapy Regulation at Risk: Attorneys

Three Ropes & Gray attorneys describe the potential for a Circuit Courts of Appeals split over FDA authority in regulating stem cell clinics.

Human Drugs

FDA Updates CRL Guidance Performance Goals

FDA publishes a revised guidance incorporating GDUFA 3 performance goals for complete response letter activities.

Human Drugs

Updated Xeloda Labeling Approved

FDA approves revised labeling for Genentechs Xeloda.

Human Drugs

FDA Extends Lynparza sNDA Review by 3 Months

FDA extends by three months its review of an AstraZeneca and Merck supplemental NDA for Lynparza (olaparib) in combination with Janssens Zytiga (abira...

Federal Register

OMB Approves Seven Information Collections

OMB approves seven information collections that include humanitarian-use devices, Right-to-Try Act reporting, and positron emission tomography drug GM...

Human Drugs

Comments on Immune-Mediated Adverse Reaction Guidance

Three drug companies comment on an FDA draft guidance on immune-mediated adverse reactions in cancer drug trials.

Federal Register

Info Collection on Fellowship/Trainee Programs

Federal Register notice: FDA sends to OMB an information collection extension entitled Conflict-of-Interest Information for Participation in Food and ...

FDA General

Independent FDA Needed to Stop Political Meddling: GAO

A new Government Accountability Office report offers recommendations to shield FDA and other HHS agencies from political interference during health em...