federal_register: 97-944

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document_number title type abstract publication_date pub_year pub_month html_url pdf_url agency_names agency_ids excerpts
97-944 Policy on Period of Marketing Exclusivity for Newly Approved Drug Products With Enantiomer Active Ingredients; Request for Comments Notice The Food and Drug Administration (FDA) is reevaluating its policy on the appropriate period of marketing exclusivity for newly approved drug products whose active ingredient is a single enantiomer of a previously approved racemate. This action is being taken to assess incentives for the development of new enantiomer drug products that may represent significant pharmaceutic advances. The agency is requesting comments on this issue and intends to publish a notice in Federal Register at a later date announcing its policy. DATES: Written comments by March 17, 1997. 1997-01-15 1997 1 https://www.federalregister.gov/documents/1997/01/15/97-944/policy-on-period-of-marketing-exclusivity-for-newly-approved-drug-products-with-enantiomer-active https://www.govinfo.gov/content/pkg/FR-1997-01-15/pdf/97-944.pdf Health and Human Services Department 221 The Food and Drug Administration (FDA) is reevaluating its policy on the appropriate period of marketing exclusivity for newly approved drug products whose active ingredient is a single enantiomer of a previously approved racemate. This action is being...

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