Regulatory Oversight and Compliance

FDA Issues Final Guidance to Amend IND Reporting Requirements.

Industry struggles to curb drug abuse, diversion, and disruptions in supply.

Regulatory approvals for new biopharmaceuticals in the United States have nearly doubled in the past decade compared with the 1990s, says a Tufts study.

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

Eastern Europe's pharmaceutical leader, Hungary, is working to maintain its number-one status while also pursuing new avenues, especially in biopharmaceuticals.

FDA, NIH and industry seek new strategies to spur drug development and promote access to therapies.

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FDA Released Draft Guidance for Industry on Safety Labeling Changes.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

Courts and Congress seek to reshape policies and programs.

FDA issued a draft guidance for industry on Mar. 11, 2011, titled User Fee Waivers, Reductions, and Refunds for Drug and Biological Products, that offers recommendations to applicants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 A similar draft guidance was issued in July 1993.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.

As drug shortages make headlines, FDA tests the Sentinel safety system and its efect on healthcare.

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

Food-safety, transparency, and counterfeit-drug growth will tax agency resources.

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.

The European Commission and Medicines Agency seem to be moving in advance of their ICH partners to update standards.

Top priorities for manufacturers include user fees, new health initiatives, and regulatory compliance.

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.

A new center may provide evidence for improving care, but could discourage coverage of treatments.

The US Food and Drug Administration issued a draft guidance last week on the Qualification Process for Drug Development Tools.

Public-private R&D partnerships are on the rise across Europe, but national goals and academia-industry competition could prevent their success at the European level.

President Obama and HHS eye innovation and countermeasures to protect public health.

The European Medicines Agency and the US Food and Drug Administration announced their individual regulatory decisions and resulting actions regarding the marketing of GlaxoSmithKline's (London) Avandia (rosiglitazone), a thiazolidinedione used to treat Type 2 diabetes.

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.