Zdrowie i gospodarka · 03/01/2001

FDA Seeks Public Comment on Proposed Changes to ANDA Regulations

The Food and Drug Administration (FDA) is seeking public comment on proposed changes to its Abbreviated New Drug Application (ANDA) regulations, specifically regarding patent and exclusivity provisions, as mandated by the Paperwork Reduction Act of 1995. The FDA must publish this notice in the Federal Register to allow 60 days for public input.