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Foley & Lardner
How are businesses across the health care and life sciences spectrum collaborating to capitalize on the commercial promise of personalized medicine.
Reed Smith
This is a quick-hit post bringing you two first-of-their-kind orders on proving causation in cases alleging inadequate drug or medical device warnings.
BakerHostetler
FDA and CDC Announced the End of a Salmonella Outbreak in Fresh Fruit – The Food & Drug Administration (FDA) completed its investigation
Reed Smith
We've brought you some great news from the gadolinium contrast agent litigation last year and the hits just keeping on coming.
Reed Smith
We would be remiss (and out of character) if we plunged into a discussion of today's case without a shout-out to "Siba,"
BakerHostetler
FDA Announces Proposed Information Collections – The Notice "announces the FDA information collection request from the OMB for a generic clearance
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.
BakerHostetler
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to advance biologics competition, the U.S. Food and Drug Administration (FDA) on February 3 published a 10-page Q&A draft guidance...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
Mintz
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)
Mintz
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 ...
Mintz
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.
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