FDA commissioner discloses effort underway to tighten oversight of changes to active pharmaceutical ingredient manufacturing processes by rewriting parts of its drug GMP regulation.

Legislative proposals described in the US FDA’s FY 2020 budget request justification document would give the agency more authority to oversee business continuity planning at pharmaceutical companies with the idea of preventing shortages of essential drugs.

Challenges ranging from fear of QC job loss to training requirements and discovery of surprise impurities confront effort to expand the use of powerful test methods for release of biopharmaceuticals.

Yet another valsartan approved as quality/shortage crisis unfolds, while warning letters hit firms on poor root cause investigations and supply chain issues, and FDA investigators procure shirt-button candid cameras.

The US, one of ICH’s original three member authorities, was spurned in favor of Canada for the pharmaceutical regulatory harmonization initiative’s next meeting in the region because of some participants’ difficulties obtaining US visas.

Pharmaceutical manufacturers and compounders are in opposition over the US FDA’s plans to carve out a place for pharmacies that want to keep physicians’ offices stocked with small amounts of product. Who will the agency disappoint this time?