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A new FDA pilot program would pre-review sponsors’ data submissions to reduce delays in oncology drug development, FDA Commissioner Scott Gottlieb said Saturday. Read More
CDER Director Janet Woodcock outlined an ambitious plan to reorganize the center’s drug reviews by centralizing project management under the Office of New Drugs. Read More
The Trump administration is urging the Supreme Court to take up a case testing whether the FDA’s refusal to approve a warning label on drugs preempts state laws that may require such labels. Read More
As part of its increased focus on drug compounding, the FDA issued a final guidance clarifying the term “outsourcing facility” and detailing requirements for compounders operating under 503A that are next to an outsourcing facility. Read More
The state may file lawsuits against additional defendants depending on the outcome of current investigations and settlement talks, according to the AG’s office. Read More
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