Agency Emergency Processing Under Office of Management and Budget Review; Orphan Drug Products; Common European Medicines Evaluation Agency/Food and Drug Administration Application Form for Orphan Medicinal Product Designation
The Food and Drug Administration (FDA) is announcing that a proposed collection of information has been submitted to the Office of Management and Budget (OMB) for emergency processing under the Paperwork Reduction Act of 1995 (the PRA). The proposed collection of information is an amendment to OMB control number 0910-0167 and concerns the joint adoption by FDA and the European Medicines Evaluation Agency (EMEA) of the Common EMEA/FDA Application Form for Orphan Medicinal Product Designation (form FDA 3671).
Medical Devices Regulated by the Center for Biologics Evaluation and Research; Availability of Summaries of Safety and Effectiveness Data for Premarket Approval Applications
The Food and Drug Administration (FDA) is publishing a list of premarket approval applications (PMAs) that have been approved by the Center for Biologics Evaluation and Research (CBER). This list is intended to inform the public of the availability through the Internet and FDA's Division of Dockets Management of summaries of safety and effectiveness data of approved PMAs.
Draft Guidance for Industry on Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment; Availability
The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry entitled ``Chronic Obstructive Pulmonary Disease: Developing Drugs for Treatment.'' This guidance is intended to assist the pharmaceutical industry in designing a clinical development program for new drugs for the treatment of chronic obstructive pulmonary disease (COPD). The emphasis of this guidance is on the assessment of efficacy of a new molecular entity in phase 3 clinical studies of COPD.
Agency Information Collection Activities; Proposed Collection; Comment Request; Application for Participation in the Medical Device Fellowship Program
The Food and Drug Administration (FDA) is announcing an opportunity for public comment on the proposed collection of certain information by the agency. Under the Paperwork Reduction Act of 1995 (the PRA), Federal agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on the application for participation in the Medical Device Fellowship Program (MDFP).