The FDA hit OTC oral gel manufacturer Europharma Concepts with a warning letter after finding significant CGMP violations at its facility in Clara, Ireland. Source: Drug Industry Daily

Sen. Ron Johnson (R-Wis.) requested a meeting with FDA Commissioner Scott Gottlieb to clear up “misconceptions” about the agency’s role in implementing the newly signed right-to-try legislation. Source: Drug Industry…

As part of its BsUFA II commitments, the FDA updated a 2015 draft guidance for biosimilar sponsors seeking formal meetings with the agency. Source: Drug Industry Daily

A new FDA pilot program would pre-review sponsors’ data submissions to reduce delays in oncology drug development, FDA Commissioner Scott Gottlieb said Saturday. Source: Drug Industry Daily

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. Source: Drug Industry Daily

Spotting shifting trends in opioid addiction and using a systematic approach to monitoring them is essential to protecting the public from the opioid crisis and intervening against it, top FDA…

The FDA hit Australian OTC drugmaker Jalco Cosmetics with a warning letter in a follow-up to a December inspection that revealed process validation and testing deficiencies at its facility in…

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. Source: Drug Industry Daily

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 —…

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…