News & Events for Human Drugs

New and updated webpages

Events

Meetings, Conferences, and Workshops

Sponsored or co-sponsored by FDA's Center for Drug Evaluation and Research (CDER)

Podcasts

Q&A with FDA

Engaging conversation and discussion about the latest regulatory topics

FDA Drug Safety Podcasts

Emerging safety information about drugs in conjunction with the release of Drug Safety Communications

Drug Information Soundcast in Clinical Oncology (D.I.S.C.O.)

Information about current topics in cancer drug development

CDER Small Business & Industry Assistance (SBIA) Chronicles

CDER SBIA Chronicles

Useful information for industry to assist in all aspects of drug marketing and regulation

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CDER Conversations

Discussions with key CDER leadership about important regulatory and policy issues

From Our Perspective

An insider's look at changes, initiatives and advances in drug development, review, and approval

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Spotlight on CDER Science

CDER Scientists describe scientific advancements aimed at improving drug development

Things to Know About...

Fast facts about CDER's efforts and actions

Novel Drugs at FDA

CDER’s New Molecular Entities and New Therapeutic Biological Products

FDA Newsroom

The latest news and events at the U.S. Food and Drug Administration (FDA)

Advisory Committee Calendar

Notices of advisory committee meetings

CDERLearn Training and Education

Learning opportunities for healthcare professionals, industry, consumers, and academia

CDER Small Business & Industry Assistance (SBIA)

A comprehensive resource for information on human drug development in regulation

Regulatory Science Impact Stories

Stories illustrating how regulatory science impacts the lives and health of people

Notable Approvals | Drugs

News about human drug-related approvals

Complex Generics News

Up-to-date information on FDA’s actions on complex generics

Center

Oct 01

E2B(R3) Electronic Transmission of Individual Case Safety Reports Implementation Guide — Data Elements and Message Specification; and Appendix to the Implementation Guide — Backwards and Forwards Compatibility

Sep 08

Temporary Policies for Compounding Certain Starter Parenteral Nutrition Drug Products for Neonates

Sep 02

Pharmacokinetics in Patients with Impaired Hepatic Function: Study Design, Data Analysis, and Impact on Dosing and Labeling

FDA Guidance Search

Drugs@FDA

Find information about most FDA-approved prescription, generic, and over-the-counter drug products

FDA Drug Shortages Database

Find information about drug shortages caused by manufacturing and quality problems, delays, and discontinuations

Orange Book

The Orange Book identifies drug products approved by FDA on the basis of safety and effectiveness

National Drug Code Directory Search

Find information about finished drug products, unfinished drugs, and compounded drug products.

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Contact FDA

Contact Point

Office of Drug Information
U.S. Food and Drug Administration
10903 New Hampshire Avenue
Building 51, Room 1109
Silver Spring, MD 20993

druginfo@fda.hhs.gov

Toll Free

(855) 543-3784

(301) 796-3400

Hours Available

Center for Drug Evaluation and Research (CDER)

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