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Sheppard Mullin Richter & Hampton
The language of the FAR reflects an intent not to require "substantial transformation" for analysis under the FAR; "manufacture" does not require substantial transformation.
Sheppard Mullin Richter & Hampton
The core responsibilities of the FDA are to promote public health by reviewing and assuring the safety, effectiveness, quality, and security of drugs, vaccines, medical devices, and several other products.
Womble Bond Dickinson
If you believe there are important reasons to test your DNA, then ask your doctor to run the tests and explain the results.
The FDA "prepared this Small Entity Compliance Guide in accordance with section 212 of the Small Business Regulatory Enforcement Fairness Act (Public Law 104-121, as amended by Public Law 110-28).
Womble Bond Dickinson
So you want to know how much Neanderthal is in your genes.
Hogan Lovells
As part of its continuing efforts to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance...
Ropes & Gray LLP
The ongoing public health crises of opioid addiction and youth vaping undoubtedly captured significant attention and enforcement resources in 2019
Continuing progress on the initiatives announced in its Biosimilars Action Plan in July 2018 (see our prior post here), the Food and Drug Administration (FDA)
As discussed in an earlier blog post, the process for reauthorizing human medical product user fee programs at the Food and Drug Administration (FDA)...
Duane Morris LLP
Beginning January 1, 2020, California, Illinois, and Nevada became the first states to ban the sale of cosmetic products and ingredients that have been tested on animals.
Mayer Brown
This market trends article examines recent trends in life sciences.
Reed Smith
If asbestos litigation reminds of the 100 Years War, and the Bone Screw litigation recalls (for us) the winning side of the Franco-Prussian War
Hogan Lovells
In 2019, the U.S. Food and Drug Administration's ("FDA" or "the Agency") Office of Prescription Drug Promotion (OPDP) issued ...
Nearly 30 years ago, the first law authorizing the Food and Drug Administration (FDA) to collect fees from drug manufacturers to expedite the review of new prescription drug applications was enacted.
Hogan Lovells
On 22 January 2020 the U.S. Food and Drug Administration (FDA or the agency) published three regulations formally classifying certain radiological image analyzers and related software,...
Dickinson Wright PLLC
The 2020 appropriations act, which was signed into law by the President on December 20, 2019, contains a mix of good and bad news for employer-sponsored health plans.
Arnold & Porter
On December 20, 2019, the Further Consolidated Appropriations Act, 2020 (Act) became law. While the Act was primarily designed to provide appropriations...
Buchanan Ingersoll & Rooney PC
Barbara Binzak Blumenfeld presented at the Phacilitate Leaders/World Stem Cell Summit conference on January 22 in Miami. Her presentation, "Regenerative Medicine Enforcement...
Fenwick & West LLP
The one-week confab centered on the Westin St. Francis Hotel in Union Square is thought to set the stage for life sciences investing for the coming 12 months.
As discussed in our article recently published by Law360, criminal health care enforcement in 2019 was in many ways a continuation of 2018, ...
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