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…the Court already enjoined.” Zogenix also alleged that the regulations violate the Contract Clause and the Commerce Clause of the U.S. Constitution, as well as the Equal Protection Clause “by…
…electrical safety, electromagnetic compatibility, software, cybersecurity, human factors, and performance (which includes bench, animal, and clinical tests). Given this, it is common for firms to contract with independent labs (“third-party…
…for Fiscal Year 2014 (“FY14”) – for a grand total of three GDUFA Warning Letters thus far (see our previous post here) – reminded us of a new interpretation the…
…at war with Eurasia” in 1984.) LDTs are Illegal. Almost as disturbing as FDA’s revised history is its bald statements that LDTs are, and always have been, illegal. FDA states,…
…use of fiber ingredients. Those changes include: FDA proposes to establish a definition for dietary fiber that is the same as the Institute of Medicine’s (IOM’s) definition of total fiber…
…Annual Report on the State of Pharmaceutical Quality. This report is not to be confused with OPQ’s Annual Report, a shorter and gauzier look into OPQ’s operations. Instead, the State…
…was enacted on July 9, 2012 as Title III of the FDA Safety and Innovation Act (“FDASIA”), established several types of user fees: application fees (original ANDA and Prior Approval…
…comments analyzing the viability of a partner program, and the existence of a potential model in the Biomedical Advanced Research and Development Authority (“BARDA”) partner program. FDA also requested public…
…and Critical Care Medicine Journal, a bi-weekly peer-reviewed medical journal published by the American Thoracic Society. The page in the brochure calls out that the data were also included in…
…for implementation in phase II, clinical decision support (CDS) tools consisting of “timely clinical information at the point of care” so that healthcare providers can access up-to-date scientific and medical…
…rather than the Executive Branch. The majority of witnesses, along with several of the Congressional members, agreed that legislation is the appropriate path to regulating laboratory developed tests. FDA, which…
…existing regulations to be repealed”. The second requirement of this “1-in-2-out” E.O. is that the total incremental costs of all new regulations, including repealed regulations, finalized this fiscal year must…
By Allyson B. Mullen – On February 18, 2014, the FDA issued the Final Guidance “Requests for Feedback on Medical Device Submissions: The Pre-Submission Program and Meetings with Food and…
…USDA’s Inspector General (IG) report confirms those doubts. The IG reviewed the process used by the National Organic Program (NOP) of the Agricultural Marketing Service (AMS) to determine equivalence of…
…and local government colleagues and pharmaceutical companies. The Commissioner also stated that he has directed the creation of a hurricane shortages task force that will be asked to identify potential…