After discovering one firm suppressed over 4,000 compounded-hormone adverse event reports, agency leans on compounders and outsourcers to improve reporting.
The US Food and Drug Administration is taking steps to improve the reporting of adverse events with compounded drugs, and aims to finalize a memorandum of understanding with states agreeable to reporting such events to the FDA when they occur at state-regulated compounding pharmacies.
This action was prompted by a recent case involving BioTE Medical, which suppressed 4,202 adverse events over a five-year period...
The UK drug regulator has introduced several changes in recent months, such as the introduction of a decentralized manufacturing regulation. Matthew Durdy, CEO of the Cell and Gene Therapy Catapult, explains what these changes mean for the cell and gene industry.
The International Council for Harmonisation has developed a holistic approach for the assessment and control of leachable impurities, supporting drug product development, registration and ongoing quality management throughout the product lifecycle.
50% tariffs on US imports from India, a range on others, an uncertain outcome of Section 232 investigations of pharma and talk of BRICS tariffs are making the forecasting environment for the pharma industry extremely difficult, the Pink Sheet finds in this infographic analysis.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
New guidance from the National Pharmaceutical Regulatory Agency responds to the medicines shortages crisis that Malaysia experienced a few years ago.
The pharmaceutical industry is edging closer to EU-wide clarity on how the bloc’s data privacy rules can be applied consistently to clinical trials and pharmacovigilance activities.
Some medicines may be subject to price rises that make them unaffordable if the burden of paying for extra wastewater treatment is not more fairly distributed across different industries, the Danish pharmaceutical industry association has warned.
