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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
The FDA will not approve generics referring to the original and discontinued formulation of Protonix IV, after a review of scientific data confirmed that therapy for gastroesophageal reflux disease was pulled off the market for safety reasons. Read More
More than a third of the applications the EMA received for central nervous system candidates raised concerns about efficacy that hindered approvals, an analysis shows. Read More
The FDA hit the Dongying Tiandong Pharmaceutical Co. with a warning letter for failing to investigate and document out-of-specification results when testing drug batches as well as GMP violations. Read More