FDA will hold a webinar regarding the proposed rule, which reiterates FDA’s assertion of jurisdiction over laboratory developed tests and proposes a phaseout of its general enforcement discretion approach.
On October 31,...more
The Agency’s recent draft guidance document on formal meetings with PDUFA product sponsors and applicants could increase opportunities for interactions between FDA and industry stakeholders.
On September 22, 2023, the US...more
FDA provides recommendations on sources of cannabis in clinical research, resources for information on quality, and control status considerations under the Controlled Substances Act.
Key Points:
..The Food and Drug...more