US FDA’s drug GMP warning letters to API suppliers tripled in 2016, driven by data integrity findings in China and India and concerns about facilities and equipment maintenance. Trend could spell trouble for commercial production and launches. While there’s no turning back the clock on supply chain globalization, there’s no turning back the clock on FDA warning letters either.
A surge in drug good manufacturing practices warning letters to active pharmaceutical ingredient suppliers last year could spell trouble for the pharmaceutical industry.
The jump in warnings to API suppliers helped drive last year’s total for drug GMP warning letters to 110, a...
While the EU's draft good manufacturing practice guideline on pharmaceutical quality systems reflects modern quality management principles, it also presents significant operational and resource challenges for drug companies.
The European Commission’s proposed update of its good manufacturing practice guideline on pharmaceutical quality system calls for smarter risk management to safeguard drug quality and supply.
A molecular target and platform technology for each indication will be selected at a November public meeting, while sustainable manufacturing issues remain ongoing.
The European Parliament has suggested clear rules on the proportion of medicinal product manufacturing that must take place in the EU, EEA, or Switzerland for drugmakers to be favored under the Critical Medicines Act, which aims to drive investment in Europe.
Ad spending changes in response to the FDA's new DTC policy could force the agency to shift the focus of its regulatory resources.
Legal and other experts discuss the need to plug data privacy and regulatory gaps and address prescription shortcuts at e-pharmacies. Collaborative models with brick and mortar chemists were also proposed.
FDA Commissioner Martin Makary also wrote in a JAMA article that the agency is not banning pharmaceutical advertising, but said industry has exploited weak enforcement.
