More than four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on starting materials for chemical entity drug substances. Read More

An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More

An alliance of pharmaceutical regulators has voiced concerns about European Commission draft guidelines relaxing some GMP requirements for advanced therapy medicinal products. Read More

Over four years after adopting an ICH guideline on manufacturing processes, the FDA has responded to industry questions on justifying starting materials for chemical entity drug substances. Read More

Regulators in Germany have cited a lab in India with litany of GMP violations and have recommended a prohibition of supply. Read More

The FDA has faulted an API maker for a host of failings at its production facility in China, including tampering with official records. Read More

Spanish regulators are recommending EU officials suspend a manufacturing certificate from a Chinese API maker over repeated issues at its plant. Read More