Executive Briefing Series (formerly The Food & Drug Letter)

The FDA issued a wide-ranging assortment of guidance documents in the last six months of 2004, including sweeping changes to its current good manufacturing practices (cGMP) to incorporate the agency’s commitment to risk-based regulations.

The last half of 2004 was a busy one on the guidance front, with the FDA releasing recommendations on a wide variety of topics, including pharmaceutical manufacturing, drug labeling and new product applications.

The FDA released a massive package of information in September generated by its two-year-long examination of existing manufacturing regulations.

A draft compliance guidance from the FDA aims to help firms understand new OTC product labeling requirements as well as prepare new labeling within prescribed implementation compliance dates.

The time it takes for a dietary supplement manufacturer to assemble the scientific information needed to support a labeling claim will depend on the product and the claimed benefits — a process that can be as short as one hour, according to the FDA.

The FDA has issued a question-and-answer draft guidance that clarifies changes made by the Medicare Modernization Act (MMA) in relation to the generic drug approval process.

The FDA will not take action against firms that submit, via annual report, postapproval manufacturing changes made to comply with an official compendium, the agency announced in a guidance document.

To ensure the quality and consistency of human gene therapies, sponsors of investigational new drug applications (INDs) should conduct ongoing studies to evaluate the identity, quality, purity and strength of the products throughout the manufacturing process, according to a draft guidance released by the FDA.

In regulations and policy statements where the term “available therapy” is not defined, the phrase should be interpreted as therapy that is specified in the approved labeling of regulated products, with only rare exceptions, according to an FDA guidance document.

The FDA hopes a draft guidance for designing and conducting pharmacokinetic (PK) studies in pregnant women will stimulate R&D of appropriate treatments for such patients.

The FDA has released a draft guidance document detailing how the agency's Center for Drug Evaluation and Research views positive findings in genetic toxicology assays during drug development.

Drugmakers submitting abbreviated new drug applications should investigate whether the drug substance under consideration can exist in polymorphic forms -- including crystalline and amorphous forms, as well as solvate and hydrate forms -- according to a draft guidance released by the FDA in December.

The FDA released two draft guidances in late December prepared under the auspices of the International Conference on Harmonisation for assessing possible cardiac risks associated with new drugs.

The FDA will delay or suspend clinical studies of drugs and biologics for human use in instances where it has evidence that a clinical investigator has violated federal safety regulations or falsified study data, the agency said in a final guidance released in September.