Building Transparency: FDA Experts Offer Essential Tips for Assembling SBOMs in Medical Devices

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

The recent discussion among experts at the Medtech conference, highlighted by the FDA, underscores the critical importance of the Software Bill of Materials (SBOM) in medical device cybersecurity. Although SBOM generation tools are still in their early stages, the consensus is clear: manufacturers must start working immediately on assembling these documents. The SBOM is now an essential regulatory requirement for “cyber devices” and crucial for managing risks and ensuring patient safety. Experts emphasize the need for simplification, the inclusion of key partners in the process, and attention to the details of the human-readable format, which complements the machine-readable format required by the FDA.

FDA Modernizes Inspections: Alternative Tools Accelerate Drug Approval

Review of Drug Master Files in Advance of Certain ANDA Submissions Under GDUFA

The FDA (Food and Drug Administration) has finalized its guidance on using alternative tools for routine inspections of drug manufacturing facilities. The measure aims to optimize the new product approval process by using remote methods to assess compliance with Good Manufacturing Practices (GMP).

Anvisa approves new HIV treatment

Brazil’s National Health Surveillance Agency (Anvisa) has approved a new drug for the treatment of HIV that combines two different substances in a single tablet.

FDA publishes ICH Q12 guideline for Post Approval CMC changes

Overview FDA facilitates the management of post approval CMC to harmonize regulatory approval of drugs with ICH Q12 guideline. This guidance applies to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device combination products that meet the definition of a pharmaceutical or biological product.  Regulatory tools and […]