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Food and Drug Administration (FDA) › Sponsors › Prescription Drugs

BakerHostetler

FDA Authorizes Florida’s Drug Importation Program

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On Jan. 5, the FDA authorized Florida’s Section 804 Implementation program (SIP), making Florida the first state to secure such approval. Generally, there are three pathways to importing a prescription drug into the United...more

BakerHostetler

FDA Issues New Guidance for Collecting Postmarketing Data on Underrepresented Patient Populations

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In a notable step toward more equitable healthcare, the U.S. Food and Drug Administration (FDA) introduced new draft guidance on August 10, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical...more

Goodwin

FDA Issues Draft Guidance on Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products and Classification...

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In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” and...more

Goodwin

FDA’s Final Q&A Guidance on Risk-Based Monitoring of Clinical Trials Provides Additional Recommendations for Sponsors

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The U.S. Food and Drug Administration (FDA) recently finalized its guidance, “A Risk-Based Approach to Monitoring of Clinical Investigations” (the “2023 RBM Guidance”) which follows up on the Agency’s March 2019 draft...more

Goodwin

Common Bioresearch Monitoring Violations: Updates from FY 2021 to Now

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The Bioresearch Monitoring Program (BIMO), run by the U.S. Food and Drug Administration (FDA), oversees the conduct of on-site inspections and data audits of FDA-regulated research in support of new product development and...more

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