Mondaq USA: Food, Drugs, Healthcare, Life Sciences > Food and Drugs Law
Jones Day
In June, the Food and Drug Administration ("FDA") published draft guidance on electronic privacy requirements for clinical trial records.
FDA still pouring over terminology decision...
Alleges advertising pumps up synthetic steroid health claims...
K&L Gates
On September 8, 2017, the Food and Drug Administration ("FDA") became the latest in a line of federal departments and agencies to seek public input on approaches to modify regulations...
Womble Carlyle
While the concept of "fake news" continues to trigger Twitter followers and grab headlines, the trade in counterfeit drugs is a worldwide problem of significant scale.
Ostrow Reisin Berk & Abrams
Most Americans are not aware of a little-known drug pricing program called the 340B Drug Discount Program (340B).
Reed Smith
The FDA recently published a draft guidance to assist industry and State and local governments in understanding how to categorize entities in the drug supply chain in accordance with the DSCSA.
Foley Hoag LLP
With changes made to the original ballot initiative, ambitious deadlines and potential challenges related to local zoning regulations...
Foley Hoag LLP
One Day after being ruled "out of order" by House leadership, Marijuana Business Daily is reporting that the Rohrabacher-Blumenauer Amendment has been extended in the House Budget....
Holland & Knight
This final guidance is the latest in a flurry of FDA publications over the past few years addressing the myriad issues associated with the burgeoning field of digital health...
Seyfarth Shaw LLP
Welcome back to The Week in Weed, your Friday look at what's happening in the world of legalized marijuana.
Foley & Lardner
Reed Smith
A couple of weeks ago, our co-blogger, Mr. McConnell, published a post on the benefits of brevity.
Akin Gump Strauss Hauer & Feld LLP
A Food and Drug Administration inspector has just knocked on your door and announced that he or she will now inspect your facility.
Haug Partners
Amanda Hamilton recently had her article "What Can the FTC Do about Orphan Drug Prices?" published in the Antitrust Health Care Chronicle for August 2017.
Foley & Lardner
In Otsuka Pharm. Co., Ltd. v. Price, the US Court of Appeals for the District of Columbia Circuit affirmed the district court decision upholding FDA's "same moiety" test for defining the zone of FDA market exclusivity periods.
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Since our March 17th post about President Trump's executive actions aiming to implement his deregulatory agenda, several important developments related to the so-called "2-for-1" Executive Order...
Holland & Knight
The requestor is a manufacturer of biologics and other pharmaceutical products (products) that require specific handling...
Dickinson Wright PLLC
Nevada Gaming Control Board Chairman Burnett, seeking to put a finer point on the question, asked the Commission if having a marijuana convention would be seen as an embarrassment for Nevada's gaming industry.
Together with new guidance regarding the potential regulatory pathways for gene therapies, the FDA announced on Monday, August 28, 2017...
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Morrison & Foerster LLP
Last month, the U.S. Supreme Court clarified the scope of specific personal jurisdiction in Bristol-Myers Squibb Co. v. Superior Court of California, San Francisco City.
Holland & Knight
The requestor is a manufacturer of biologics and other pharmaceutical products (products) that require specific handling...
Mintz, Levin, Cohn, Ferris, Glovsky and Popeo, P.C.
Picking up from my last installment of this series exploring the regulatory history of off-label communication, this post highlights some recent trends in FDA enforcement and guidance related to off-label promotion.
Foley & Lardner
To register, a business performing telemedicine services must submit an application and registration fee.
Reed Smith
We've generally been skeptical of state "Right To Try" statutes, for several reasons. First, to the extent that they try to circumvent the FDCA, they're likely to be preempted.
McDermott Will & Emery
The US Court of Appeals for the Federal Circuit reversed the district court and found that a Supply and Purchase Agreement between Helsinn and third-party MGI Pharma, Inc. (MGI) before the critical date of the asserted patents constituted a sale of the claimed invention. The court concluded that, after the Leahy-Smith America Invents Act (AIA), the details of the
Reed Smith
We've posted a lot about Plavix recently but all in the context of the Supreme Court's decision in BMS v. Superior Court on personal jurisdiction. So, we don't blame you if you forgot that the product at issue in that case was Plavix.
McDermott Will & Emery
Purchasers of Takeda Pharmaceuticals Company's branded diabetes drug, ACTOS, filed an antitrust suit alleging that Takeda falsely described two patents to the US Food and Drug Association (FDA)...
Day Pitney LLP
Implementation of the final rule, originally released in January and previously discussed here, had already been postponed three times this year, most recently until October 1, 2017.
Foley & Lardner
The Federal Circuit first addressed Hospira's argument that the Federal Circuit lacked jurisdiction to review the district court's interlocutory order.
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