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Latest FDA News and Information

FDA approves first human papillomavirus test for primary cervical cancer screening

The U.S. Food and Drug Administration today approved the first FDA-approved HPV DNA test for women 25 and older that can be used alone to help a health care professional... read more

FDA proposes to extend its tobacco authority to additional tobacco products, including e-cigarettes

As part of its implementation of the Family Smoking Prevention and Tobacco Control Act signed by the President in 2009, the U.S. Food and Drug Administration today proposed a new... read more

FDA approves Sylvant for rare Castleman's disease

The U.S. Food and Drug Administration today approved Sylvant (siltuximab) to treat patients with multicentric Castleman?s disease (MCD), a rare disorder similar to lymphoma (cancer of the lymph... read more

FDA proposes new expedited access program for medical devices that address unmet medical needs

Today, the U.S. Food and Drug Administration proposed a new program to provide earlier access to high-risk medical devices that are intended to treat or diagnose patients with serious... read more

Food and Drug Adminstration (FDA): CDRHNew

Summary Information for: cobas® HPV Test

Labeling, Approval Order, and Summary of Safety and Effectiveness for cobas® HPV Test (P100020S008).

Federal Register: Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the draft guidance entitled "Balancing Premarket and Postmarket Data Collection for Devices Subject to Premarket Approval." This draft guidance clarifies FDA&... read more

Federal Register: Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating Disease or Conditions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

The FDA is announcing the availability of the draft guidance entitled "Expedited Access for Premarket Approval Medical Devices Intended for Unmet Medical Need for Life Threatening or Irreversibly Debilitating... read more

Federal Register: Food and Drug Administration Transparency Initiative: Increasing Public Access to the Food and Drug Administration's Compliance and Enforcement Data; Availability

As part of the Transparency Initiative, the Food and Drug Administration (FDA) is announcing the availability of a report entitled "Food and Drug Administration Transparency Initiative: Increasing Public Access... 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

Clinical Investigator Status (Biologics)

Clinical Investigator Inspection List updated through 3/11/2010.

Summary Basis for Regulatory Action - ALPROLIX

Complete List of Currently Approved Premarket Approvals (PMAs)

Information updated through March 31, 2014

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