Ilenna J. Stein

Ilenna J. Stein

Holland & Knight LLP

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FDA Issues New Drug Compounding and Outsourcing Facility Guidance - The New Policy Documents Clarify FDA's Expectations and...

The FDA issued multiple policy documents on July 1, 2014, to implement the Compounding Quality Act (CQA). Congress enacted the CQA in November 2013 as part of the Drug Quality and Security Act (DQSA), in response to the...more

7/10/2014 - DQSA Drug Compounding FDA Pharmaceutical Prescription Drugs

Massachusetts Public Health Council Approves Regulations Implementing Relaxation of Strict Ban on Gifts from Pharmaceutical and...

On November 21, 2012, the Massachusetts Public Health Council (PHC) approved the final regulatory amendments implementing the Pharmaceutical and Medical Device Manufacturer Conduct Law, MGL ch. 111N, which was amended by Gov....more

12/3/2012 - Medical Devices Pharmaceutical Physician Gift-Ban Law Sunshine Act

Massachusetts Relaxes Strict Ban on Gifts from Pharmaceutical and Medical Device Manufacturers to Physicians

Governor Deval Patrick signed into law Massachusetts’ fiscal year 2013 budget on July 8, 2012. The budget includes amendments to the state’s Pharmaceutical and Medical Device Manufacturer Conduct Law, MGL ch. 111N. The...more

7/12/2012 - Manufacturers Medical Devices Pharmaceutical Physician Gift-Ban Law Physicians Reporting Requirements

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