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The Food and Drug Administration (FDA) has announced the release of draft guidance titled "Developing Drugs for Optical Imaging." This guidance aims to provide advice to drug sponsors on designing clinical trials to develop and approve optical imaging drugs used with imaging devices during surgeries. Optical imaging drugs help surgeons identify tumors and differentiate them from normal tissue, enhancing surgical safety and effectiveness. Public comments on the draft can be submitted until April 8, 2025, although feedback is welcomed anytime.

The Food and Drug Administration (FDA) is establishing a public docket to gather comments about using a Type V Drug Master File (DMF) for submitting Model Master Files (MMFs) in support of Abbreviated New Drug Applications (ANDAs). MMFs contain detailed information about computer-simulated models used in drug development. The FDA is seeking feedback from the public and interested parties to improve the sharing and acceptance of these models. Comments must be submitted electronically or in writing by April 17, 2025.

The National Institutes of Health announced upcoming closed meetings for the Center for Scientific Review. These meetings, scheduled for January 7 and January 14, 2025, will review and evaluate grant applications related to drug development and topics in immunology and infectious diseases. The meetings will be held virtually due to confidentiality concerns over discussing sensitive information such as trade secrets and personal data. The announcement was made on December 16, 2024, as part of the Federal Advisory Committee Act.

The Center for Scientific Review, part of the National Institutes of Health, is holding several closed meetings to review grant applications. These meetings are not open to the public to protect confidential information, including trade secrets, commercial property, and personal information. The meetings will occur virtually between April 8 and April 30, 2025, covering various topics such as immunology, autoimmunity, HIV/AIDS, and drug development. Each meeting will be attended by a named scientific review officer from the NIH, ensuring the review process is handled professionally.