The Central Drugs Standard Control Organization (CDSCO) is seeking feedback a proposed risk-based pharmacovigilance inspection model. CDSCO plans to adopt a four-year cycle for pharmacovigilance ...

After formally adopting API Standard 653 for its tank inspection and repair program, Colonial Pipeline Co, Atlanta, Ga., has developed procedures based on risk-management principles to level the load ...

Key steps for organizations and their counsel to take and issues to consider when developing and implementing a risk-based due diligence program for investigating third parties in commercial ...

DLA Piper's Vernessa Pollard (left) and FDA Marty Makary (right) spoke at the FDLI Annual Conference on Wednesday. Marty Makary, the Commissioner of the US Food and Drug Administration (FDA), ...

As part of a pilot program that launched in April, the agency is conducting shorter, focused screening assessments to ...

The Bureau of Safety and Environmental Enforcement (BSEE) this week announced the implementation of a new Risk-Based Inspection Program that employs a systematic framework to identify facilities and ...

The Food and Drug Administration has released new produce regulatory program standards to help align state and federal inspections. The standards cover inspector training, foodborne illness response, ...

On February 2, 2026, the U.S. Food and Drug Administration (FDA) published its anticipated compliance program manual, Inspection of Medical Device Manufacturers (CP 7382.850), to explain how the ...

At-a-Glance: Offshore platform integrity management is a risk-based, lifecycle program that preserves containment and structural fitness by integrating RBI/FFS assessments, targeted inspections/NDT, ...

On February 2, 2026, the U.S. Food and Drug Administration’s long-awaited harmonization of the medical device good manufacturing practice regulations with the international ISO 13485 standard, Medical ...