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After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than press for the use of new synthetic substitutes. Read More
After a lengthy review, the U.S. Pharmacopeia (USP) has decided to continue recommending the use of decades-old reagents derived from horseshoe crab blood for detecting endotoxins in drugs rather than press for the use of new synthetic substitutes. Read More
The FDA issued a warning letter to Wilson Medicine Company citing serious quality problems found during a Feb. 26-March 1 inspection of its OTC manufacturing facility in Nandore, India. Read More
The FDA issued a compounding policy priorities plan for 2018, highlighting manufacturing standards for outsourcing facilities and collaboration with state regulators. Read More
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More
The FDA pharmaceutical inspector of tomorrow will be more specialized by training and more likely to work abroad, according to a high-ranking agency official. Read More
The European Commission released new GMP guidelines for manufacturers of advanced therapy medicinal products that adapts existing European Union GMP guidelines to the specific characteristics of ATMPs and calls for a risk-based approach. Read More
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