Regulatory Authority Actions

The generic-drug manufacturer Actavis reached an agreement on a consent decree of permanent injunction with the US Food and Drug Administration regarding the company?s US subsidiary Actavis Totowa LLC.

The US Food and Drug Administration issued a draft guidance, Genotoxic and Carcinogenic Impurities in Drug Substances and Products: Recommended Approaches.

A US Food and Drug Administration guidance issued Tuesday provides new recommendations to applicants who wish to designate proposed products as orally disintegrating tablets (ODTs).

The US Food and Drug Administration released a draft guidance document that contains questions and answers relating to new labeling requirements for over-the-counter drug (OTC) products that are marketed without an approved application under section 502(x) of the Dietary Supplement and Nonprescription Drug Consumer Protection Act of 2006.

The US Food and Drug Administration has released Guidance for Industry: Cooperative Manufacturing Arrangements for Licensed Biologics, which finalizes the draft from August 1999.

The US Food and Drug Administration issued a draft guidance, Contents of a Complete Submission for the Evaluation of Proprietary Names, on Nov. 24, 2008.

The US Food and Drug issued a draft guidance on Tuesday, Nov. 18, titled Process Validation: General Principles and Practices for comment. The guidance is meant to serve as a revision to the 1987 Guideline on General Principles of Process Validation.

The US Food and Drug Administration released a draft guidance that reviews the agency's plan to offer priority-review vouchers to companies developing new treatments for neglected tropical diseases.

The US Food and Drug Administration issued a new draft guidance for public comment on sterile manufacturing.

The US Food and Drug Administration has distributed a draft of Guidance for Industry: Residual Solvents in Drug Products Marketed in the United States for public comment.

Bristol-Myers Squibb (BMS) agreed to reduce the output of ozone-depleting refrigerants at several industrial facilities around the country to resolve violations of the Clean Air Act. The company's modifications will cost approximately $3.65 million.

The US Food and Drug Administration published a Draft Guidance for Industry on Providing Regulatory Submissions in Electronic Format in the Federal Register on July 11.

Pfizer has agreed to pay $975,000 in civil penalties to resolve alleged violations of the Clean Air Act at its former manufacturing plant in Groton, Connecticut, according to a release by the US Department of Justice.

The European Pharmacopeia Commission has published the General Information chapter "Potentially Genotoxic Impurities and European Pharmacopoeia Monographs on Substances for Human Use" in the July 2008 edition of PharmEuropa.

The US Food and Drug Administration issued a new guidance Monday on indexing structured product labeling. The Center for Biologics Evaluation and Research and the Center for Drug Evaluation and Research will begin indexing structured product labeling in the product labeling for human drug and biologic products.

Problems associated with contamination of heparin products continue after worldwide recalls in March in the United States, Italy, France, and Denmark.

The US Food and Drug Administration issued a final guidance last week regarding investigational new drug applications for human gene therapy.

The US Food and Drug Administration released a final guidance on protocol for testing sterile products.

The US Food and Drug Adminstration?s Center for Biologics Evaluation and Research has issued a Warning Letter to Genzyme Corporation.

The US Food and Drug Administration issued a final guidance, Manufacturing Biological Intermediates and Biological Drug Substances Using Spore-Forming Microorganisms, which provides recommendations that allow for greater flexibility when manufacturing biological products with spore-formers.

A new guidance issued by the US Food and Drug Administration earlier this month advises companies on how to treat polymorphic drug compounds?those that exhibit multiple structural forms?in filing abbreviated new drug applications.

Rockville, MD (May 31)-The US Food and Drug Administration issued a draft guidance on how to design bioequivalence (BE) studies for specific drug products to support abbreviated new drug applications (ANDAs).

Rockville, MD (May 31)-The US Food and Drug Administration finalized guidances for seasonal and pandemic influenza vaccines, outlining the regulatory pathways for developing and approving these products.

Rockville, MD (May 1)-The US Food and Drug Administration issued a guidance to alert pharmaceutical manufacturers, pharmacy compounders, repackers, and suppliers to the potential public health hazard of glycerin contaminated with diethylene glycol (DEG), a poison.

The US Food and Drug Administration issued a guidance document to provide manufacturers of biological products (other than blood and blood components) with its current thinking on reporting requirements on deviations from current good manufacturing practices for biological products.

Rockville, MD (Oct. 2)-The US Food and Drug Administration has issued its final Guidance for Industry: Quality Systems Approach to Pharmaceutical CGMP Regulations.

Rockville, MD (Sept. 28)-The US Food and Drug Administration has released the draft guidance for industry ?Characterization and Qualification of Cell Substrates and Other Biological Starting Materials Used in the Production of Viral Vaccines for the Prevention and Treatment of Infectious Diseases.?

Rockville, MD (Sept. 28)-The US Food and Drug Administration has withdrawn three guidances for industry: ?Providing Submissions in Electronic Format?NDAs? (e-NDA), ?Providing Regulatory Submissions in Electronic Format?ANDAs? (e-ANDA), and ?Providing Regulatory Submissions in Electronic Format: Annual Reports for NDAs and ANDAs.? These documents all recommend submitting information as portable document files (PDFs) or as SAS transport files.

Washington, DC (Sept. 1) - In a Federal Register announcement the US Food and Drug Administration laid out its guidance agenda for the coming months.

The US Food and Drug Administration has published a draft guidance, Q4B Regulatory Acceptance of Analytical Procedures and/or Acceptance Criteria (RAAPAC).