New guidance for FDA communication issued
The way in which the FDA plans to pass along drug safety information to the public has been finalized in the guidance Drug Safety InformationFDA's Communication to the Public. According to the agency, the document is intended to ensure that emerging drug safety information is available in a balanced, impartial manner so that healthcare professionals and patients can consider the information when making decisions about medical treatments, despite uncertainties in the data. The various methods to be utilized include Public Health Advisories, Patient Information Sheets, Healthcare Professional Sheets, and Alerts on Patient Information. The new guidance also describes the role of the Drug Safety Oversight Board. The FDA's safety postings can be accessed at
FDA’s Recent Exemptions: What Do They Mean as We Finalize DSCSA Implementation?
October 31st 2024Kala Shankle, Vice President of Regulatory Affairs with the Healthcare Distribution Alliance, and Ilisa Bernstein, President of Bernstein Rx Solutions, LLC, discussed recent developments regarding the Drug Supply Chain Security Act.
