Jill Wechsler is Pharm Exec's Washington Corespondent
"Sunshine" Policy Continues To Exempt CME Funding
November 3rd 2014A federal policy issued late last week appeared to deal a serious blow to continuing medical education (CME) programs supported by biopharma companies. But the specifics published by the Centers for Medicare and Medicaid Services (CMS) Oct. 31, 2014 actually continue to exempt independent CME funding from the Open Payments reporting requirements for transfers of value from manufacturers to prescribers.
Global Gaps in Standards Threaten Biosimilar Development
September 24th 2014Although biopharmaceutical companies and regulatory authorities have made considerable progress in establishing policies for bringing biosimilars to market, key differences and gaps in requirements for testing and documenting product similarity still characterize the European Union, the U.S. and other regions.
NIH Translational Research Partnership Yields Promising Therapy
July 18th 2014A potential treatment for sickle cell disease has come through the “valley of death” of early stage development due to support from a collaborative partnership established by the National Center for Advancing Translational Sciences (NCATS) at the National Institutes of Health (NIH).
US Regulators and Industry Bodies Push Forward with Global Expansion
June 18th 2014At the annual meeting of the Food and Drug Law Institute (FDLI) this year, FDA commissioner Margaret Hamburg concluded her keynote address by describing a “dramatically changing global marketplace” and its “huge implications” for FDA’s ability to ensure the safety and quality of products manufactured elsewhere.