Drug GMP Report

CDER Director Janet Woodcock plans to refocus the center’s efforts on the FDA’s GMPs for the 21st Century initiative now that she is permanent director of the drugs center.

While the UK’s Medicines and Healthcare products Regulatory Agency (MHRA) supports the European Commission’s (EC) proposal to combat drug counterfeiting, it says certain requirements conflict with UK regulations.

The FDA will attempt to hire more than 1,300 biologists, chemists, medical officers, mathematical statisticians, investigators, inspectors and other professionals by Sept. 30, the end of the fiscal year.

The FDA got a boost last month after the Senate approved amendments to H.R. 2642, a bill granting the agency an immediate $275 million infusion that will help the FDA fund more inspections.

Although the pharmaceutical industry is concerned about facility registration fees included in a draft bill to fund FDA import safety activities, Rep. Frank Pallone (D-N.J.) said the fees would be necessary.

Baxter is refuting charges made last month by China’s State Food and Drug Administration (SFDA) that the company did not cooperate with Chinese inspectors during an audit of its heparin finished dose plant in New Jersey.

When the new U.S. Pharmacopeia (USP) standard for controlling residual solvents in pharmaceuticals takes effect July 1, the FDA will require all generic drugs to comply with it, not just those with USP monographs, according to the Office of Generic Drugs (OGD).

Elge, an OTC private label contract manufacturer, received a warning letter for inappropriate use of U.S. Pharmacopeia (USP) tests to identify incoming active pharmaceutical ingredients (APIs) for its cough and allergy products.

After learning that a transport trailer carrying 9,000 vials of high-value injectable medications was stolen while in transit in Tennessee, Johnson & Johnson (J&J) is recalling several lots of the drugs associated with the shipment.

A Maryland-based contract manufacturer entered into a consent decree with the FDA for distributing unapproved prescription cough syrups containing hydrocodone that were manufactured under conditions that did not meet GMPs.

The FDA and the European Medicines Agency (EMEA) will pilot a joint GMP inspections program as a new priority under their bilateral agreement.

Leiner Health Products agreed to forfeit $10 million and plead guilty to one count of wire fraud under a proposed settlement with the Justice Department concerning charges that the firm manipulated stability data at its OTC production facility.

With the FDA anticipating publishing fiscal year (FY) 2009 drug user fees this August, the agency is asking manufacturers to provide a list of products and finished-dose manufacturing facilities subject to such fees by June 16.

Boehringer Ingelheim recalled 2.2 million Zantac tablets last month because the drug exceeded limits for S-oxide, an impurity.

The FDA will start mining Medicare Part D prescription drug claims databases this month as the agency kicks off its Sentinel initiative, a program designed to transform its postmarket surveillance system through public and private partnerships.

With deadlines looming, many sponsors remain concerned that their intellectual property rights may be threatened by mandatory online databases of clinical trial results.

The FDA’s launch of Sentinel, an initiative designed to transform the agency’s postmarket surveillance, will likely not place additional regulatory burdens on devicemakers, according to an agency director.

While registering clinical trial results in online databases is becoming mandatory in the U.S., the World Health Organization (WHO) is looking to create voluntary worldwide standards for reporting trial results.

The FDA’s Center for Devices and Radiological Health (CDRH) has upgraded its CeSub, a free electronic submissions program, with a new tool to collect submission data and reduce lengthy review times.

More than 30 communities are in the running for a demonstration project that will provide Medicare incentive payments to physicians that use certified electronic health records (EHRs) to improve the quality of patient healthcare.