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Latest FDA News and Information

Statement from FDA Commissioner Robert Califf, M.D. announcing new draft guidances on medical product communications

We recognize that there is a high level of interest regarding FDA?s views on communications about medical products. We are committed to an ongoing dialogue with industry and other... read more

FDA and EPA issue final fish consumption advice

Today, the U.S. Food and Drug Administration and the U.S. Environmental Protection Agency issued final advice regarding fish consumption. This advice is geared toward helping women who are... read more

FDA approves first drug for spinal muscular atrophy

The U.S. Food and Drug Administration today approved Spinraza (nusinersen), the first drug approved to treat children and adults with spinal muscular atrophy (SMA), a rare and often fatal... read more

FDA permits marketing of new tissue expander for women undergoing breast reconstruction following mastectomy

The U.S. Food and Drug Administration today allowed marketing of a new tissue expander system for soft tissue expansion in two-stage breast reconstruction following mastectomy and in the treatment... read more

Food and Drug Adminstration (FDA): CDRHNew

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities - Questions and Answers

Drug and Device Manufacturer Communications with Payors, Formulary Committees, and Similar Entities - Questions and Answers

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140022, DEN160005, DEN150056 added)

Evaluation of Automatic Class III Designation (De Novo) Summaries (DEN140022, DEN160005, DEN150056 added)

Medical Product Communications that are Consistent with the FDA-required Labeling - Questions and Answers

Medical Product Communications that are Consistent with the FDA-required Labeling - Questions and Answers

Check the CDRH Customer Satisfaction Results

This page provides real time results for CDRH's customer satisfaction survey.

What's New: Vaccines, Blood & Biologics RSS Feed

Guidance Agenda: Guidance Documents CBER is Planning to Publish During Calendar Year 2017

Guidance agenda outling guidance documents CBER is planning to publish during calendar year 2017.

Biologics Guidances

Clinical Investigator Status (Biologics)

Clinical Investigator Inspection List from inspections of clinical investigators who have conducted studies with investigational new drugs or investigational devices reviewed by CBER

Jobs at the Center for Biologics Evaluation and Research (CBER)

Interdisciplinary Scientist, Closes: 4/23/2010; Supervisory Contract Specialist (Direct Hire), Closes: 12/31/2010

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