Food & Drug Law Blog

On Wednesday, April 23, 2014 by Michael A. Walsh posted in Food & Drug Law Blog
In February 2014, the Food and Drug Administration (FDA) opened a docket entitled “FDA’s Standards for the Interoperable Exchange of TI, TH and TS Information for Tracing of Human Finished, Prescription Drugs.”

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On Friday, April 18, 2014 by Michael A. Walsh posted in Food & Drug Law Blog
 On April 15, 2014, in Zogenix v Deval Patrick 1:14-cv-11698-RWZ, the U.S. District Court in Massachusetts ruled that the Commonwealth overstepped its power to regulate the practice of pharmacy and medicine by, effectively reversing the Food and Drug Administration’s (FDA’s) approval of the opioid analgesic Zohydro ER.

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On Monday, March 10, 2014 by Michael A. Walsh posted in Food & Drug Law Blog
 On February 7, 2014, the Federal Trade Commission (FTC) filed its response brief in the DC Circuit Court in In the Matter of POM Wonderful LLC, et al.  POM is a notorious litigant, and this chapter in its voluminous book of litigation began in September of 2010  as a declaratory judgment action in the District Court for the District of Columbia (10-cv-1539).  

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On Wednesday, February 26, 2014 by Michael A. Walsh posted in Food & Drug Law Blog
In August 2013, the Food and Drug Administration (“FDA”) announced the Secure Supply Chain Pilot Program (the “Pilot Program”).  On February 18, 2014, the FDA announced the start of the Pilot Program with thirteen (13) prequalified companies who will receive expedited entry for up to five (5) drug products. The Pilot Program is intended to assist FDA in its efforts to prevent the importation of adulterated, misbranded, or unapproved drugs by allowing the FDA to focus its resources on imported drugs that fall outside the program. The Pilot Program is a voluntary 2 year program that will run through February 2016. Under the Pilot Program, products are given “May Proceed” status without review or examination. The term “May Proceed” means that an FDA-regulated imported product may proceed into domestic commerce based on electronic screening.

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On Tuesday, February 11, 2014 by Michael A. Walsh posted in Food & Drug Law Blog
On February 5, 2014, the Food and Drug Administration (FDA) published a proposed rule (here) concerning the Sanitary Transportation of Human and Animal Food. The proposed rule establishes sanitary transportation practices “for shippers, carriers by motor vehicle and rail vehicle, and receivers engaged in the transportation of food.” 


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