The Pediatric Committee (PDCO) of the European Medicines Agency (EMA) has revised the current list of class waivers for medicines that are not required to submit a pediatric investigation plan.
To mark the 50th anniversary of the adoption of the first European Union (EU) pharmaceutical legislation, the European Commission is organizing a one-day conference that will take place in Brussels September 28.
Navitas, a regulatory service provider, announced that it has opened a new Latin America hub in Bogota, Colombia. Navitas' expansion into Latin America offers bilingual resources (Spanish and English) and provides document, report and submission level publishing for simple and complex submission applicatioms.
The pilot involved several CDER employees working together with OEA employees to respond to drug related inquiries posted on FDA’s Facebook page.
Acorn Regulatory, an ISO-certified medical device and pharmaceutical consulting firm, has customized programs to help U.S. manufacturers of drug-device combinations in meeting European regulatory approvals.