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Food and Drugs Law
United States
Alston & Bird
Whether you are looking to enter the market or grow your footprint in the industry, you need to know what regulations are relevant and how to prepare to bring a dietary supplement to market.
The next post in our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs ...
Alston & Bird
This week, HHS awarded $103 million to address mental health in the health care workforce and $13 million to increase access to behavioral health care services in rural America. Read more about these funds and other news below.
Jones Day
Generic drug makers often use "skinny labels" to carve out approved indications that are covered by an innovator's patents, and thus to avoid liability for inducing infringement.
Michael Best & Friedrich
The folks at Food Safety News, with help from the non-profit organization STOP Foodborne Illness, published this article earlier this month providing a "crystal ball"...
Morrison & Foerster LLP
Last week the FDA announced that it would lift regulations controlling what can be called "French dressing."
Continuing our series analyzing the recently proposed Contract Year 2023 Policy and Technical Changes to the Medicare Advantage and Medicare Prescription Drug Benefit Programs rules (Proposed Rule)...
Proskauer Rose LLP
On December 31, 2021, New York Governor Kathy Hochul signed landmark legislation to increase the transparency of prescription drug pricing and to establish requirements on pharmacy middlemen.
Ropes & Gray LLP
On January 6, 2022, the Centers for Medicare & Medicaid Services ("CMS") issued a proposed rule entitled "Medicare Program; Contract Year 2023 Policy and Technical Changes to the Medicare
Morrison & Foerster LLP
Morrison & Foerster and the Berkeley Center for Law & Technology (BCLT) have teamed up to present a biweekly podcast addressing recent Federal Circuit decisions.
Riker Danzig Scherer Hyland & Perretti
86 FR 73860: Centers for Medicare & Medicaid Services ("CMS") has issued a final rule establishing methodologies for adjusting the Medicare durable medical equipment, prosthetics...
A clinical trial is a research study conducted in humans designed to help clinical investigators evaluate the safety and effectiveness of a new drug.
Alston & Bird
Below is Alston & Bird's Health Care Week in Review, which provides a synopsis of the latest news in healthcare regulations, notices, and guidance...
Duane Morris LLP
On January 1, 2022, the updated Code on Interactions with Health Care Professionals, published by the Pharmaceutical Research and Manufacturers of America (PhRMA), became effective.
Alston & Bird
Just before the New Year holiday, the FDA announced it that was suspending non-mission-critical domestic and foreign inspection activities.
Husch Blackwell LLP
The meat processing sector has been in the crosshairs of the federal government over that last several years due to increased consumer prices for meat products and complaints from farmers and ranchers.
Alston & Bird
Many year-end publications often feature a look back at the highlights of the previous year. Candidly, there are few things that we would rather put in our rearview mirrors...
Frankfurt Kurnit Klein & Selz
In December 2020, the U.S. Food and Drug Administration proposed to revoke its definition and standard of identity for French dressing, which was first instituted back in 1950.
Sheppard Mullin Richter & Hampton
On December 22, 2021, the Food and Drug Administration (FDA) published draft guidance documents for manufacturers of devices that were issued Emergency Use Authorizations (EUAs)...
Buchanan Ingersoll & Rooney PC
The Centers for Medicare and Medicaid Services released a proposed National Coverage Determination decision memorandum that would cover Food and Drug Administration (FDA)-approved monoclonal antibodies ...
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