Regulatory Authority Actions

The US Food and Drug Administration recently published guidance for the characterization and qualification of cell substrates, viral seeds, and other biological materials used to manufacture viral vaccines for human use.

FDA Releases Annual Guidance Agenda; OMB Urges Obama to Issue Revised Executive Order.

New York Governor Wants Stricter Limits On Pharmaceutical Marketing; And More.

Also, FDA and WebMD increase collaboration and PPD is awarded contract to evaluate the agency's postmarket spontaneous-adverse-event surveillance system.

The US Food and Drug Administration issued a guidance for industry and review staff titled, Labeling for Human Prescription Drug and Biological Products-Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information.

The US Food and Drug Administration published its first draft guidance for industry about Risk Evaluation and Mitigation Strategies (REMS) on Sept. 30, 2009.

The US Food and Drug Administration last week issued the final draft of its guidance for industry titled Labeling of Nonprescription Human Drug Products Marketed Without an Approved Application as Required by the Dietary Supplement and Nonprescription Drug Consumer Protection Act: Questions and Answers.

Also, FDA issues several recent enforcement letters to Cambrex, Johnson & Johnson, and Pedinol.

The US Food and Drug Administration?s Draft Guidance for Industry?Process Validation: General Principles and Practices provides a life-cycle approach for validating pharmaceutical processes and aims to help pharmaceutical companies achieve consistently high product quality.

US Food and Drug Administration Commissioner Margaret Hamburg outlined last week six initial steps designed to improve the effectiveness and timeliness of FDA's regulatory and enforcement system.

The US Food and Drug Administration released its Guidance for Industry titled Pharmaceutical Components at Risk for Melamine Contamination.

The US Food and Drug Administration last week posted the final version of its Guidance for Industry, ANDAs: Impurities in Drug Substances.

The US Food and Drug Administration issued a draft guidance for industry, Incorporation of Physical-Chemical Identifiers into Solid Oral Dosage Form Drug Products for Anticounterfeiting, on July 13.

To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.

To address the increasing popularity of drug-injector systems, the US Food and Drug Administration last week released a Draft Guidance for Industry titled, Technical Considerations for Pen, Jet, and Related Injectors Intended for Use with Drugs and Biological Products.

The US Food and Drug Administration released a new guidance for industry, Medication Guides-Adding a Toll-Free Number for Reporting Adverse Events, on June 8, 2009.

This week the US Food and Drug Administration released the final version of Guidance for Industry: Providing Regulatory Submissions in Electronic Format-Drug Establishment Registration and Drug Listing.

The US Food and Drug Administration posted a draft guidance for industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion, on its website May 26, that describes factors the agency considers when evaluating advertisements and promotional labeling for prescription drugs and medical devices.

The US Food and Drug Administration issued a draft guidance for industry, Label Comprehension Studies for Nonprescription Drug Products, in the May 1 Federal Register.

The author describes various manufacturing processes and evaluates whether the guidance can be applied to each of them.

The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the common technical document (CTD) format, including the electronic CTD (eCTD).

The US Food and Drug Administration issued a draft guidance for industry on the Submission of Summary Bioequivalence Data for Abbreviated New Drug Applications (ANDAs).

The US Food and Drug Administration issued 14 untitled letters last week to pharmaceutical companies in violation of the Federal, Food, Drug, and Cosmetic Act for publishing misleading and misbranded information about their drug products online.

On March 3, the US Food and Drug Administration released a draft guidance for Industry entitled "Clinical Pharmacology Section of Labeling for Human Prescription Drug and Biological Products: Content and Format."

The US Food and Drug Administration has released a draft guidance for industry entitled Influenza: Developing Drugs for Treatment and/or Prophylaxis.

Also, UCB will divest certain business in emerging markets to GSK; the KineMatik Group named Michael G. Jarjour president and CEO; more...

Last week, the US Food and Drug Administration issued a draft guidance for industry, Standards for Securing the Drug Supply Chain–Standardized Numerical Identification for Prescription Drug Packages, and launched a pilot program to help protect the pharmaceutical supply chain.

The US Food and Drug Administration issued its Draft Guidance for Industry on Submission of Laboratory Packages by Accredited Laboratories.

A draft guidance for industry titled "Good Importer Practices" has been released to provide importers guidance on the steps they can take to help ensure imported products comply with the relevant statues and regulations of the United States throughout a product's lifecycle.

The US Food and Drug Administration announced that it had filed a Consent Decree on Dec. 23, 2008 and was awaiting the court?s entry of a permanent injunction that bars Actavis (Hafnarfjordur, Iceland), its officers Sigurdur Oli Olafsson and Douglas Boothe, and its subsidiary Actavis Totowa (Totowa, NJ) from manufacturing and distributing drugs at the Actavis Totowa facilities.