Searching Content indexed under Food and Drugs Law by WilmerHale ordered by Published Date Descending.
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House Passes Historic SAFE Banking Act
The US House of Representatives recently passed the Secure and Fair Enforcement (SAFE) Banking Act, H.R. 1595 (the Act).
United States
9 Oct 2019
Developments In The Marijuana Industry And The Implications For Financial Institutions
The myriad—and conflicting—state, federal and international laws governing the burgeoning marijuana industry have created a complicated legal landscape for financial institutions.
United States
11 Feb 2019
False Claims Act: 2018 Year-In-Review
Federal False Claims Act recoveries in fiscal year 2018 amounted to $2.88 billion, down by roughly $600 million from the prior year and dropping below $3 billion for the first time in eight years.
United States
9 Jan 2019
Blurred Vision – Cannabis And Reporting
On 17 October, Canada legalised the recreational use of marijuana, following the passing of The Cannabis Act 2018 this summer.
21 Nov 2018
United States
18 May 2018
False Claims Act: 2017 Year-In-Review
False Claims Act (FCA) recoveries topped $3.7 billion in fiscal year 2017, marking the eighth straight year of annual recoveries in excess of $3 billion.
United States
10 Jan 2018
Practice Tips for Patentees Asserting Method-of-Treatment Claims Involving Divided
Do physicians ‘‘condition participation'' of drug therapy based on patients' compliance with drug manufacturer instructions regarding how to take drugs? Do physicians withhold medically necessary drug therapy from patients when patients fail or refuse to take a drug in accordance with the instructions in the label?
United States
4 Apr 2017
3rd Circ. Weighs In On Product-Hopping
On Sept. 28, 2016, in Mylan Pharmaceuticals Inc. v. Warner Chilcott Public Limited Co. (Doryx),[1] the Third Circuit affirmed the lower court's grant of summary judgment rejecting antitrust claims brought against Warner Chilcott for alleged "product hopping" with respect to its drug Doryx (delayed-release doxycycline hyclate).
United States
5 Nov 2016
Doryx: Third Circuit Affirms Dismissal Of Product Hopping Claim
On September 28, 2016, in Mylan Pharmaceuticals Inc. v. Warner Chilcott Public Limited Co., the Third Circuit affirmed the lower court's grant of summary judgment against antitrust claims by generic manufacturer Mylan.
United States
30 Sep 2016
‘Follow-On Biologics': Ensuring Continued Innovation In The Biotechnology Industry
New protein products will likely need more market protection than what is provided to new drug products.
United States
12 Aug 2016
Stay Versus Stay: How Litigation Stays Pending IPRs Impact the 30-Month
Upon initiation of a patent infringement action between branded and generic pharmaceutical companies, the Hatch-Waxman Act (21 U.S.C. § 355(j)) provides for an automatic 30-month stay of
United States
30 Mar 2016
Inside Views: Learning From Ebola
In 1976, Yambuku village school headmaster Mabalo Lokela felt sick when he returned from a trip to northern Zaire near the Central African Republic border. He had a high fever, diarrhea, and bleeding.
United States
16 Jul 2015
US Supreme Court Issues Unanimous Ruling In Favor Of WilmerHale Client POM Wonderful
On June 12, 2014, the US Supreme Court ruled unanimously in favor of WilmerHale client POM Wonderful LLC (POM) in an important case involving the intersection of the Lanham Act’s prohibition on false advertising and the Federal Food, Drug, and Cosmetic Act's (FDCA) regulation of food and beverage labeling.
United States
18 Jun 2014
Fourth Circuit Holds cGMP Violations Do Not Create False Claims Under Medicare And Medicaid
In the first appellate decision of its kind, the U.S. Court of Appeals for the Fourth Circuit held on Friday, February 21, that because compliance with the Food and Drug Administration's (FDA) Current Good Manufacturing Practices (cGMP) regulations is not a precondition for reimbursement under Medicare and Medicaid, violations of the cGMP regulations by themselves cannot form the basis for False Claims Act (FCA) claims under those programs.
United States
25 Feb 2014
FDA Issues Draft Guidance on Cybersecurity Considerations in Premarket Submissions for Medical Devices
The Food and Drug Administration recently issued draft guidance on the content of premarket submissions for management of cybersecurity in medical devices.
United States
26 Jun 2013
Medical Device Excise Tax Set To Become Effective January 1, 2013
Beginning January 1, 2013, a 2.3 percent excise tax will be imposed on sales of "taxable medical devices" by manufacturers and importers.
United States
20 Dec 2012
Pricing And Reimbursement For Pharmaceuticals In The European Union: European Commission Proposes Revised Transparency Directive
Today, the European Commission adopted its proposal for a new Directive relating to the transparency of measures regulating the pricing of medicinal products for human use and their inclusion in the scope of public health insurance systems ("Transparency Directive" or "Directive"), which is set to replace the current Transparency Directive 89/105/EEC in place since 1989.
European Union
14 Mar 2012
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