📊FDA Notice on Good Manufacturing Practices for PET Drugs
Agency Information Collection Activities; Proposed Collection; Comment Request; Current Good Manufacturing Practices for Positron Emission Tomography Drugs
Summary
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (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 collection of information under FDA's current good manufacturing practice (CGMP) regulations for positron emission tomography (PET) drug products. PET is a medical imaging modality involving the use of a unique type of radiopharmaceutical drug product.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$$ - High
The notice involves regulatory compliance requirements related to the collection of information on Current Good Manufacturing Practices (CGMP) for PET drugs, impacting pharmaceutical businesses. Facilities must meet FDA standards, requiring them to allocate resources for recordkeeping, testing, and reporting.