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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21 CFR Parts 315 and 601

The Food and Drug Administration (FDA) is reopening until February 12, 1999, the comment period for the draft guidance for industry entitled ‘‘Draft Guidance for Industry on Developing Medical Imaging Drugs and Biologics’’ that appeared in the Federal Register of October 14, 1998 (63 FR 55067). FDA is taking this action in response to a request for an extension. DATES: Written comments on the d...

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration 21

The Food and Drug Administration (FDA) is proposing to amend the final monograph for over-thecounter (OTC) bronchodilator drug products to remove pressurized metered-dose aerosol container dosage forms for the ingredients epinephrine, epinephrine bitartrate, and racepinephrine hydrochloride. This action is being taken because the OTC marketing of such drug products will require an approved appl...

Overlooking subvisible particles in therapeutic protein products: gaps that may compromise product quality.

aDepartment of Pharmaceutical Sciences, Center for Pharmaceutical Biotechnology, University of Colorado Health Sciences Center, Denver, CO 80262 bDepartment of Chemical and Biological Engineering, Center for Pharmaceutical Biotechnology, University of Colorado, Boulder, CO 80309 cDivision of Drug Delivery Technology, Leiden/Amsterdam Center for Drug Research (LACDR), Leiden University, Leiden, ...

MOLECULAR BIOLOGY OF HUMAN IMMUNODEFICIENCY VIRUSES: HIV-l AND HIV-2

Lessons learned from independent central review.

Independent central review (ICR) is advocated by regulatory authorities as a means of independent verification of clinical trial end-points dependent on medical imaging, when the data from the trials may be submitted for licensing applications [Food and Drug Administration. United States food and drug administration guidance for industry: clinical trial endpoints for the approval of cancer drug...