Telix unveils radiopharmaceutical spinoff Rhine Pharma following string of nuclear medicine acquisitions
fkansteiner
Tue, 10/22/2024 – 14:31

The Food and Drug Administration (FDA or the Agency) is extending the comment period for the notice that appeared in the Federal Register of September 20, 2024. In the notice, FDA requested comments on the draft guidance for industry and FDA staff entitled "Chemical Analysis for Biocompatibility Assessment of Medical Devices." The Agency is taking this action in response to a request for an extension to allow interested persons additional time to submit comments.

The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Drug Interaction Information in Human Prescription Drug and Biological Product Labeling." The draft guidance is intended to assist applicants in developing the DRUG INTERACTIONS section of labeling as described in FDA regulations for the content and format of labeling for human prescription drug and biological products. The purpose of the draft guidance is to provide recommendations on what information to include in, and how to present and organize the information within, the DRUG INTERACTIONS section of labeling for human prescription drug and biological products to enhance communication of clinically significant drug interactions and facilitate the safe and effective use of prescription drugs by healthcare practitioners.