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FDA issues draft guidance on drug facility inspections

USA - July 23 2013 On July 15, 2013, the Food and Drug Administration (FDA) issued a draft guidance that describes the circumstances that, in the agency's view, will...

Allison Reschovsky.

Sunshine in Europe for pharmaceutical companies?

USA, European Union - July 11 2013 On June 24th, the European Federation of Pharmaceutical Industries and Associations (EFPIA) adopted a "Disclosure code of transfers of value to...

Genevieve Michaux.

Supreme Court ruling casts antitrust cloud on “pay for delay” patent settlements common in pharmaceutical industry

USA - June 18 2013 In a decision that will likely have a significant impact on the pharmaceutical industry (and possibly broader implications for patent, antitrust, and...

D. Bruce Hoffman, David A. Higbee, Gary C. Messplay, Sheldon T. Bradshaw, Melvin H. Orlans.

Court dismisses challenge to prescription drug copayment coupon program

USA - June 6 2013 On June 3, 2013, the US District Court for the Southern District of New York dismissed a putative class action alleging that a prescription drug...

Sharon M. Bradley.

FDA issues draft guidance recommending utilization of robust quality agreements in contract drug manufacturing arrangements

USA - May 30 2013 On May 28, 2013, the US Food and Drug Administration (FDA) published a draft guidance entitled "Contract Manufacturing Arrangements for Drugs:...

Sheldon T. Bradshaw.