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CP Pharmaceuticals, a subsidiary of drug manufacturer Wockhardt Limited received a warning letter that inspection of its facility revealed significant GMP violations. Read More
The FDA issued a Form 483 to Baxalta after an inspection revealed a litany of observations including two from an earlier inspection that were not corrected. Read More
The House last night approved a new version of the 21st Century Cures bill after removing a provision on drug company payments to physicians that would have prevented its passage in the Senate. Read More
The lowest-cost patient-centered initiatives — such as involving advisory groups and offering patient counseling and education — led to the largest returns in clinical trial performance. Read More
Taking into account industry criticism, the FDA has loosened the data requirements that drugmakers will have to meet to determine the admissibility of imports entering the U.S. Read More