Medical Device Legal News with Sam Bernstein: Episode 11
In January 2025, various US Food and Drug Administration (FDA) centers and offices published their guidance agendas for the 2025 calendar year (CY). These agendas provide valuable insights into FDA’s regulatory priorities,...more
In recent years, Congress and the U.S. Food and Drug Administration (“FDA”) have sought to reform the accelerated approval process, an expedited development and approval pathway for drugs that provide meaningful therapeutic...more
The Food and Drug Administration (FDA) updated a final guidance and a companion draft guidance (the “first draft guidance”) providing answers to questions related to the agency’s regulation of biosimilar products and its...more