The Federal Register

Current Good Manufacturing Practice and Investigational New Drugs Intended for Use in Clinical Trials

Tue, Jul 15 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is amending the current good manufacturing practice (CGMP) regulations for human drugs, including biological products, to exempt most phase 1 investigational drugs from complying with the regulatory CGMP requirements. FDA will continue to exercise oversight of the manufacture of these drugs under FDA's general statutory CGMP authority and through review of the investigational new drug applications (IND).

In addition, elsewhere in this issue of the Federal Register, FDA is announcing the availability of a guidance document entitled ``Guidance for Industry: CGMP for Phase 1 Investigational Drugs'' dated November 2007 (the companion guidance). This guidance document sets forth recommendations on approaches to compliance with statutory CGMP for the exempted phase 1 investigational drugs.

FDA is taking this action to focus a manufacturer's effort on applying CGMP that is appropriate and meaningful for the manufacture of the earliest stage investigational

Determination That SANOREX (Mazindol) Tablets 1 and 2 Milligrams Were Not Withdrawn From Sale for Reasons of Safety

Tue, Jul 15 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing its determination that SANOREX (mazindol) Tablets, 1 and 2 milligrams (mg), were not withdrawn from sale for reasons of safety or effectiveness. This determination will allow FDA to approve abbreviated new drug applications (ANDAs) for mazindol tablets if all other legal and regulatory requirements are met.

Global Harmonization Task Force, Study Groups 1 and 3; Proposed and Final Documents; Availability

Tue, Jul 15 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of final and proposed documents that have been prepared by Study Groups 1 and 3 of the Global Harmonization Task Force (GHTF), respectively. These documents represent a harmonized proposal and recommendation from the GHTF Study Groups that may be used by governments developing and updating their regulatory requirements for medical devices. These documents are intended to provide information only and do not describe FDA's current regulatory requirements; elements of these documents may not be consistent with current U.S. regulatory requirements. In particular, FDA seeks comments on the advantages and disadvantages of the approaches in the GHTF documents, particularly where they are not consistent with current practices for the manufacturer of products distributed within the United States.

Guidance for Industry: Current Good Manufacturing Practice for Phase 1 Investigational Drugs; Availability

Tue, Jul 15 2008 11:00:00 GMT

The Food and Drug Administration (FDA) is announcing the availability of a document entitled ``Guidance for Industry: CGMP for Phase 1 Investigational Drugs'' dated July 2008. The guidance provides assistance in applying relevant current good manufacturing practice (CGMP) requirements of the Federal Food, Drug, and Cosmetic Act (the act) to the manufacture of most investigational new drugs, including biological drugs, used in phase 1 clinical trials. FDA is issuing this guidance concurrently with a final rule published elsewhere in this issue of the Federal Register specifying that compliance with FDA's CGMP regulations is not required for most investigational drugs that are manufactured for use in phase 1 clinical trials. Therefore, FDA is recommending the approaches outlined in this guidance for complying with the statutory CGMP requirements in the act. The guidance announced in this notice finalizes the draft guidance entitled ``INDsApproaches to Complying with CGMP During Phase 1'' dated Ja