Executive Briefing Series (formerly The Food & Drug Letter)

One of the more momentous developments in FDA policymaking so far this year was the agency’s announcement that it was delaying the release of a long-awaited guidance document detailing scientific issues on follow-on biologics.

A revised guidance document has been released that spells out when new drug applications (NDAs) for the marketing of botanical drug products are required and when such products can be marketed under an OTC drug monograph.

Guidance documents on product labeling, advertising, botanical drugs and a variety of other topics have been released by the FDA this year, but so far no guidance on follow-on biologics is available.

The much-anticipated guidance detailing scientific issues on follow-on biologics will not be released this summer as originally announced.

A workshop to address the scientific issues surrounding follow-on biologics will be held in early fall, after which the FDA will release its long-awaited guidance on the issue, the acting FDA chief told lawmakers.

The FDA announced in a final International Conference on Harmonisation (ICH) guidance that drugmakers that have been requested by a regulatory authority to file product information that spans several periodic safety update reports (PSURs) should file a summary bridging report (SBR).

Three final guidances have been released that will help firms prepare and submit applications for medical imaging drugs and biological products -- agents that are used solely to diagnose and monitor diseases or conditions rather than to treat them.

The FDA, citing past lapses in the rules governing drug testing samples, has issued a final guidance on how drugmakers and others should handle reserve testing samples used in bioavailabilty (BA) and bioequivalence (BE) studies that support new and generic drug applications.

In a revised guidance, the FDA says that makers of combined oral contraceptives (OCs) should simplify patient labeling sections and incorporate more clinical trial data in their labeling.

The FDA commissioner said his agency will release in August a multicenter analysis of current good manufacturing practices (cGMPs).

Drug manufacturers who adopt recommendations contained in one of two draft guidances on direct-to-consumer advertising released by the FDA may be able to cut advertising costs and better educate consumers, agency officials said.

To verify whether an institution or individual investigators have a financial stake in the outcome of research, the HHS Office of Public Health and Science has recommended in a new final guidance document that institutions involved in FDA-regulated clinical research establish conflict of interest committees (COICs).