Regulatory Authority Actions

FDA Issues Final Guidance to Amend IND Reporting Requirements.

FDA issued a new guidance for industry concerning the submission of summary bioequivalence data for abbreviated new drug applications.

FDA recently published guidance for preventing the cross-contamination of finished pharmaceuticals and active pharmaceutical ingredients with nonpenicillin beta-lactam antibiotics.

FDA Released Draft Guidance for Industry on Safety Labeling Changes.

New Web Search Feature on FDA.gov, Search for Product Recalls More Quickly

FDA issued a draft guidance for industry on Mar. 11, 2011, titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants seeking such actions under the Federal Food, Drug, & Cosmetic Act (FD&C Act). A similar draft guidance was issued in July 1993. The new document clarifies the types of waivers, refunds, and reductions available under the user-fee provisions of the FD&C Act as well as the procedures for handling these requests, including how to appeal an FDA decision.

Last Thursday, FDA filed a consent decree of permanent injunction against McNeil, a subsidiary of Johnson & Johnson, for failing to comply with current good manufacturing practice requirements. The action prevents McNeil from manufacturing and distributing drugs from its Fort Washington, Pennsylvania, facility until FDA determines that its operations comply with the law.

FDA announced on Mar. 2, 2011, that it is taking action against companies that manufacture, distribute, or market certain unapproved prescription oral cough, cold, and allergy products, according to an agency release.

On Feb. 4, 2011, the European Medicines Agency released new document on drug products that are manufactured using stem cells.

FDA published its long-awaited guidance titled Process Validation: General Principles and Practices this week.

Johnson & Johnson's run of quality issues, recalls and other bad news continues with yet another product recall.

FDA issued a draft guidance for industry on Jan. 18, 2011, about the size of beads within drug products labeled for sprinkle.

During the 20 months before the crisis of contaminated heparin in early 2008, the US Food and Drug Administration did not inspect any Chinese heparin firms, according to a US Government Accountability Office, (GAO) report.

Pfizer (New York) announced on Oct. 29, 2010 that it intends to recall two additional lots--approximately 38,000 bottles--of Lipitor (atorvastatin calcium) 40 mg tablets distributed in the United States.

The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.

Amgen (Thousand Oaks, CA) issued a voluntary recall last week of certain lots of Epogen(R) and Procrit(R) (Epoetin alfa) vials.

The US Food and Drug Administration recently issued a Warning Letter to Bristol-Myers Squibb (BMS, New York) for violations of current good manufacturing practice at the company's Manati, Puerto Rico, manufacturing facility.

The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.

Europe needs a more standardised and consistent approach for supplying excipient information to the regulators.

About one month after the announcement of McNeil Consumer Healthcare's recall of children's liquid pain and allergy medications , the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue.

Genzyme (Cambridge, MA) signed a consent decree of permanent injunction that requires the company to correct manufacturing-quality violations at its Allston, Massachusetts, manufacturing facility.

McNeil Consumer Healthcare is voluntarily recalling all lots that have not yet expired of certain over-the-counter children's and infants' liquid products.

New Draft Guidance for Solid Oral Dosage Forms Focuses on Physical Chemical Identifiers. This article is part of PharmTech's supplement "Solid Dosage and Excipients 2010."

FDA made available a draft guidance that would expand the information disclosed about conflict-of-interest waivers.

Genzyme provided an update on its manufacturing operations following the issuance of a draft consent decree by FDA regarding the company's Allston Landing, Massachusetts, manufacturing plant.

FDA Issues Warning Letter To Pfizer; And More.

FDA Issues Warning Letters to Six US Medical Spas; and More.

In an attempt to strengthen safeguards against counterfeit, diverted, subpotent, misbranded, adulterated, or expired drugs, FDA issued a new final guidance for industry.

Biotechnology company Genzyme reported that FDA notified the company that it intends to take enforcement action to ensure that products are made in compliance with good manufacturing practice (GMP) regulations.

FDA issued a new guidance for industry to help new drug applicants write the dosage and administration section of their products' labels.