Podcast - Credit Funds: How PE Funds Can Address and Minimize Conflict When Expanding Into Credit
FDA is now accepting submissions to the Commissioner’s National Priority Voucher (CNPV) pilot program, and with only five vouchers to be awarded as part of the initial year of the program, the competition is anticipated to be...more
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
In a notable step toward more equitable healthcare, the U.S. Food and Drug Administration (FDA) introduced new draft guidance on August 10, Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical...more
In August 2023, the Food and Drug Administration issued two draft guidance, both related to the development of biosimilar products, entitled “Formal Meetings between the FDA and Sponsors or Applicants of BsUFA Products” and...more
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
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