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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
Ogletree, Deakins, Nash, Smoak & Stewart
In August of 2019, HHS issued guidance stating that it would not enforce the April final rule until new guidance was issued.
Reed Smith
The Department of Health and Human Services (HHS) has modified HIPAA retail pharmacy transaction requirements to differentiate between partial fill ...
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,"
Sheppard Mullin Richter & Hampton
As promised, here is a summary of some key provisions in CMS' proposed rule relating to the Medicare Advantage and Part D programs for contract years 2021 and 2022.
Lewis Roca Rothgerber Christie LLP
The Alcohol and Tobacco Tax and Trade Bureau, the agency which regulates alcohol beverages at the federal level, recently posted several educational videos about the history of the Federal Alcohol Administration Act ...
BakerHostetler
FDA Announces Proposed Information Collections – The Notice "announces the FDA information collection request from the OMB for a generic clearance
Reed Smith
The phrase may be biblical in origin, coming from the story of Cain and Abel, but its meaning certainly persists and has relevance today.
Singh & Associates
This section of the newsletter discusses recent drug approvals from U.S. Food and Drug Administration (USFDA) for various serious diseases.
Reed Smith
Given the quantities of drugs that these programs purchase, and the age of the regulation, we'd call this a big deal.
Reed Smith
Mention the Third Restatement of Torts and the learned intermediary rule in the same sentence, and our response would be to cite §6(d) of the product liability part of the Restatement
Sheppard Mullin Richter & Hampton
Joining host Michael Cohen to explore the evolving regulations surrounding the food industry are two guests, Michael Roberts and Sascha Henry.
Seyfarth Shaw LLP
Recently, the Trump Administration issued its proposed Notice of Benefit & Payment Parameter for 2021 regulations.
McDermott Will & Emery
On October 11, 2017, the Alcohol and Tobacco Tax and Trade Bureau (TTB) reopened the comment period for the following three notices of proposed rulemaking
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.
BakerHostetler
Legislation to address surprise medical bills is moving forward this week, as two House committees mark up their own plans to protect patients.
Reed Smith
On January 28, 2020, the Food and Drug Administration (FDA) announced that the Office of Prescription Drug Promotion (OPDP)
Mintz
As we recently detailed in another blog post, Massachusetts is one of several states considering legislation that would require ...
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