Investigational drugs Archives - Lachman Consultant Services, Inc.

Right to Try Final Rule for Reporting Under the Act To Publish On Wednesday

By Bob Pollock Sep 13, 2022 FDA IND Investigational drugs Regulatory Affairs

In today’s prepublication of the Federal Register appears the final rule entitled Annual Summary Reporting Requirements Under the Right to Try Act (here). The Trickett Wendler, Frank Mongiello, Jordan McLinn, and Matthew Bellina, Right to Try Act of 2017 (Right to Try Act), was signed into law on May 30, 2018. This Act provides an […]

Aug

Revised Q&A Guidance on Charging for Investigational Drugs Issued by FDA

By Bob Pollock Aug 23, 2022 Charging FDA IND Investigational drugs Regulatory Affairs

While FDA has allowed charging for investigational drugs since the 1987 “Charging Rule” went into effect, the Agency has been responding to questions from industry ever since. In 2009, the FDA revised the Charging Rule itself. The revised guidance (here) discusses these changes and notes that the “FDA’s regulations on charging for investigational drugs under […]

Investigational drugs

Right to Try Final Rule for Reporting Under the Act To Publish On Wednesday

Revised Q&A Guidance on Charging for Investigational Drugs Issued by FDA

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