2 Day Virtual FDA and EU Annex 15 Process Validation Guidance & Requirements Training ...

The FDA Process Validation training highlights opportunities in enhancing comprehension of constant process verification aligned with lifecycle concepts. It addresses early R&D phases through ...
Regulatory Affairs Professionals Society

FDA draft guidance sets impurity controls for most antibiotics

The US Food and Drug Administration (FDA) has released a draft guidance document aimed at setting impurity limits for ...
MobiHealthNews

FDA releases revised draft guidance on CDS software, final guidelines on ‘device ...

This morning the FDA released two guidance documents relating to the regulation of various digital health software devices. The first is a draft guidance outlining categories of clinical decision ...
BioSpace

FDA bolsters bespoke therapy framework with new draft safety guidelines

The draft guidance supports the agency’s new pathway designed to speed up the development of custom gene therapies.
JD Supra

FDA Publishes New Draft Guidance on Regenerative Medicine Therapies

The U.S. Food and Drug Administration (FDA) issued new draft guidance on Sept. 20, 2025, surrounding expedited programs for regenerative medicine therapies for serious conditions. The draft guidance ...
Medical Marketing & Media

Behind the FDA’s push to enact new legislation to restrict DTC ads further

The FDA has quietly proposed legislation that would give it more authority to deem drugs misbranded in pharma DTC ads. But ...
JD Supra

New FDA Guidance Could Speed Biosimilar Approvals and Cut Costs

The FDA released draft guidance indicating it may approve certain biosimilars without requiring a comparative efficacy study (CES), traditionally a costly and time-intensive step. Instead, advances in ...
ABC 7 Chicago

FDA issues new sodium guidelines, renewing pressure for food makers to use less salt

WASHINGTON -- The US Food and Drug Administration said Wednesday it will be lowering its targets for sodium content in processed, packaged, and prepared foods, but not to levels recommended for ...