On 19 December 2016, the European Medicines Agency (“EMA”) published an updated version of the EMA guidance document concerning post-authorisation procedural advice for users of ...24 January 2017
Compromise Legislative Proposal on Regulation of Compounding Pharmacies Released
The legislation will resolve the 1st Amendment and severability issues relating to section 503A of the Food, Drug and Cosmetic Act. These issues have previously impeded FDA's efforts to take enforcement actions against pharmacies engaged in large scale commercial compounding. With these changes, it is anticipated that FDA will move to limit the ability of pharmacies to compound large quantities of drugs without a prescription and further restrict them from making versions of commercially available drugs that are essentially copies of the marketed drug. The bill also establishes new regulatory requirements for large scale compounders, which will now have to become registered "outsourcing facilities."
Regulation (EU) No 536/2014 of 16 April 2014 on clinical trials on medicinal products for human use, and repealing Directive 2001/20/EC (“the Clinical Trials Regulation”) was...24 January 2017
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published a draft strategy for developing pharmacopoeial public quality standards for biological...20 January 2017