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
FTC Closes Seven-Year Adderall XR Pay-for-Delay Investigation
Given the FTC's very recent amicus brief in In re Effexor, however, the closing of the Adderall XR investigation should not be taken as an indication that the agency is abandoning its scrutiny of these provisions. Instead, this development may suggest that the FTC is carefully weighing the fact that these types of provisions can vary significantly both in form and competitive effect.
Finally, it is important to note that the Adderall XR agreements are still the subject of private litigation currently pending in federal court in the Southern District of New York.
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