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
Federal judge allows discovery to proceed in REMS duty to deal dispute
It is worth noting that despite the FTC's recent efforts to become involved in private antitrust suits involving the pharmaceutical industry (see here and here), it was unable to participate in the proceedings due to the recent government shutdown.
For additional background on the case and the issues, please refer to this article.
The UK Medicines and Healthcare products Regulatory Agency (“MHRA”) has published guidance for companies submitting a Manufacturing Authorisation application or variation on...06 January 2017
On 16 December 2016, the European Medicines Agency (“EMA”), along with the European Biopharmaceutical Enterprises (“EBE”) organised the fifth annual regulatory...03 January 2017