Category: United States

Brazil’s Pharmacovigilance Framework: From RDC 406/2020 to RDC 967/2025

Anvisa

The Brazilian Health Regulatory Agency (ANVISA) is intensifying enforcement against the dangerous practice of using cosmetics as injectables and reinforcing the strict adherence to Good Manufacturing Practices (GMP). Understand the regulatory implications for the cosmetics and medical device sectors in Brazil and the associated risks.

Tighter Route: FDA Will Require Randomized Controlled Trials (RCTs) for CAR T-Cell Therapy Approval

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

Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.

Clarity and Truth in Advertising: FDA Finalizes Guidance on Promotional Labeling for Biologics and Biosimilars

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

Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.

Navigating Regulatory Processes a Governmnet Reopens

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

Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.

The Pharmaceutical Industry Calls for Expansion of the FDA’s PreCheck Program

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

Numerous US pharmaceutical industry groups are urging the Food and Drug Administration (FDA) to expand the scope of the recently launched PreCheck Program. Initially focused on accelerating the establishment of new domestic manufacturing facilities, the industry is now advocating for the inclusion of existing factories and the integration of PreCheck with current regulatory initiatives. The main goal is to maximize the program’s impact to rapidly strengthen supply chain resilience and support the generic drug sector.

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).

FDA’s Updates on Dietary Supplement Regulation in 2025

The FDA regulates dietary supplements under the Dietary Supplement Health and Education Act of 1994 (DSHEA).
Unlike pharmaceuticals, supplements do not require FDA approval before being marketed.
However, manufacturers are responsible for ensuring the safety of their products and accurate labeling.
In 2025, the FDA announced a major reorganization by establishing the Human Foods Program (HFP), aiming to modernize and strengthen the evaluation of food ingredients and dietary supplements.

IMDRF Releases Key Guidance Documents for Medical Device Software

IMDRF Releases Key Guidance Documents for Medical Device Software

The International Medical Device Regulators Forum (IMDRF) has released two key guidance documents to support the regulation of medical device software. These include Good Machine Learning Practice for Medical Device Development: Guiding Principles (IMDRF/AIML WG/N88 FINAL:2025) and Characterization Considerations for Medical Device Software and Software-Specific Risk (IMDRF/SaMD WG/N81 FINAL:2025). These documents aim to enhance global regulatory harmonization and assist medical device manufacturers in navigating compliance requirements for software-based and AI-driven technologies.

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