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Latest FDA News and Information

Indictment of FedEx Corporation for Illegally Distributing Prescription Drugs

The U.S. Attorney for the Northern District of California today charged the FedEx Corporation with conspiring with two separate but related online pharmacy organizations to distribute controlled substances and... read more

FDA approves new product to treat rare genetic disease

The U.S. Food and Drug Administration yesterday approved Ruconest, the first recombinant C1-Esterase Inhibitor product for the treatment of acute attacks in adult and adolescent patients with hereditary... read more

Update on findings in the FDA cold storage area on the NIH campus

As previously reported, on July 1, 2014, biological samples were found in the cold storage area of U.S. Food and Drug Administration laboratories on the National Institutes of Health campus. The... read more

United States enters consent decree with New York dietary supplement manufacturer

Triceutical, Inc., of Farmingdale, New York, and Liqun Zhang, the company?s president, have agreed to stop production and distribution of dietary supplements under the terms of a consent decree... read more

Food and Drug Adminstration (FDA): CDRHNew

Federal Register: Agency Information Collection Activities; Proposed Collection; Comment Request; 513(g) Request for Information

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

Class I Medical Device Recall: Diabetic Supply of Suncoast, Inc., Advocate Redi-Code+ BMB-BA006A Blood Glucose Test Strips ? Labeling Error May Lead to Use of Incorrect Glucose Meters

A labeling error omitting the test strips model number (BMB-BA006A) could lead to use of the Advocate Redi-Code+ BMB-BA006A blood glucose test strips manufactured by BroadMaster Bio-Tech Corp.... read more

Documents MDSAP AU P0026.001 and MDSAP AU P0027.001 added to MDSAP Audit Procedures and Forms

MDSAP Audit Procedures and Forms

Evaluation of Automatic Class III Designation (De Novo) Summaries (K123250 added)

Evaluation of Automatic Class III Designation (De Novo) Summaries (K123250 added)

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

Providing Submissions in Electronic Format ? Postmarketing Safety Reports for Vaccines

Draft Guidance for Industry: Determining the Need for and Content of Environmental Assessments for Gene Therapies, Vectored Vaccines, and Related Recombinant Viral or Microbial Products

Guidance for Industry and FDA Staff: IND Applications for Minimally Manipulated, Unrelated Allogeneic Placental/Umbilical Cord Blood Intended for Hematopoietic and Immunologic Reconstitution in Patients with Disorders Affecting the Hematopoietic System

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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