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Latest FDA News and Information

FDA approves Trulance for Chronic Idiopathic Constipation

The U.S. Food and Drug Administration today approved Trulance (plecanatide) for the treatment of Chronic Idiopathic Constipation (CIC) in adult patients.

Statement from FDA Commissioner Robert Califf, M.D. announcing FDA Oncology Center of Excellence launch

Today the U.S. Food and Drug Administration is establishing the Oncology Center of Excellence (OCE) and appointing Dr. Richard Pazdur as its director. This will make oncology the first... read more

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

Food and Drug Adminstration (FDA): CDRHNew

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; Adverse Event Program for Medical Devices (Medical Product Safety Network)

The FDA is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal Agencies are... read more

Federal Register: Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers; Draft Guidance for Industry and Review Staff; Availability

The FDA is announcing the availability of the draft guidance ``Drug and Device Manufacturer Communications With Payors, Formulary Committees, and Similar Entities--Questions and Answers.'' This draft guidance provides... read more

Federal Register: Manufacturer Communications Regarding Unapproved Uses of Approved or Cleared Medical Products; Availability of Memorandum; Reopening of the Comment Period

The FDA is reopening the comment period for the notification of public hearing, published in the Federal Register of September 1, 2016 (81 FR 60299) concerning our comprehensive review of our regulations and policies... read more

Federal Register: Medical Product Communications That Are Consistent With the Food and Drug Administration-Required Labeling--Questions and Answers; Draft Guidance for Industry; Availability

The FDA is announcing the availability of the draft guidance ``Medical Product Communications That Are Consistent With the FDA-Required Labeling--Questions and Answers.'' This draft guidance provides information for... read more

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

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

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

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