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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
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
CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited received a warning letter that inspection of its facility revealed significant GMP violations. Read More