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The resolution of all original symptoms should be the primary efficacy endpoint in trials for complicated urinary tract infection drugs, according to a new FDA guidance. Read More
Stepping up its pace from just three recommendations in April, the EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended nine drugs for approval at its May meeting — including two orphan drugs. Read More
Adolescents should be allowed to join adult oncology clinical trials as long as the cancer or the drug target is the same in both adults and adolescent patients, the FDA has suggested. Read More
The Commission’s goal is to create a more competitive climate along with increased transparency and protections against the entry into EU member state markets by IP-infringing products. Read More
Press Secretary Sarah Sanders said the White House could not provide further details, “but we do expect some specific policy pieces to come out on that soon.” Read More
FDA Commissioner Scott Gottlieb said the agency may ask Congress for more authority to deal with intravenous drug shortages but he also called for voluntarily collaboration by the industry. Read More
In the latest development over alleged misconduct by Insys in promoting its fentanyl-based opioid Subsys, a former sales representative admitted to participating in a scheme to bribe doctors to prescribe the drug under the pretext of paying speaking fees. Read More
The FDA called out brand drugmakers for using REMS to delay and block competitive generic drugs, announcing two draft guidances designed to help generic drug makers get their products to market and preserve the safety controls intended by REMS. Read More
Post-approval change management protocols submitted and approved after approval of the original application should be accompanied by an updated product lifecycle management document. Read More