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As part of its Safer Consumer Products Regulation (SCPR) under California’s Green Chemistry Initiative, the Department of Toxic Substances Control (DTSC) on September 13, 2014 issued its Draft Priority Product Three-Year Work...more
The U.S. Food & Drug Administration regulates new drug approvals in a process that is extremely thorough, lengthy and expensive. Regulations apply to a drug candidate’s product development phase, the approval process and...more
In This Issue:
- ALJ Upholds Denial of Sales Tax Refund Because Vendor Failed to First Make Refunds to Customers
- HMO Held Exempt from New York City General Corporation Tax
- State Tax Department Issues...more
Within several months of Securities and Exchange Commission Chair Mary Jo White’s announcement in late 2013 of a commitment to improving the SEC’s trial readiness, the Commission suffered a number of losses in federal...more
As a manufacturer of generic drug products, undoubtedly one of your goals is to prepare an Abbreviated New Drug Application (ANDA) that will pass regulatory scrutiny efficiently. Your ANDA submission is a culmination of time,...more
On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed consent process...more
Three recently issued draft guidance documents (Draft Guidances) from the U.S. Food and Drug Administration (FDA or Agency) are designed to assist manufacturers in product communications via social media and other interactive...more
A New York State Division of Tax Appeals administrative law judge (ALJ) recently ruled in favor of a medical device and technology company on the question of whether patent license fees that the company charged to its...more
Under Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 3(e), a registrant may distribute or sell its registered product under another person's name and address instead of (or in addition to) its own without...more
In nearly identical decisions released on May 27, 2014, Sandoz Canada Inc v Canada, 2014 FC 501 (Sandoz) and ratiopharm Inc v Canada, 2014 FC 502 (ratiopharm), the Federal Court of Canada held that some licensees of patents...more
Amazon’s ambitious proposal to use a fleet of unmanned aircraft systems to deliver packages may seem like a novelty announced years before its time, but the commercial use of unmanned aircraft systems is already here. The...more
New market exclusivity opportunities emerge for pharmaceutical companies.
In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more
Fixed-dose combination drug products are becoming increasingly important in the treatment of patients with diabetes, cardiovascular disease, and infectious disease. Within the last two decades, the U.S. Food and Drug...more
Exemption for Custom Devices Remains Narrow -
On January 14, 2014, the U.S. Food and Drug Administration (FDA or “the Agency”) released a draft guidance document titled Custom Device Exemption. The draft guidance...more
Two new FDA guidance documents can assist both conventional beverage and liquid dietary supplement manufacturers to avoid costly mischaracterization and enforcement action.
The US Food and Drug Administration (FDA or...more
On January 13, 2014, the Food and Drug Administration (“FDA”) issued a draft guidance document outlining the circumstances under which a manufacturer of a prescription drug or biological product may be accountable for content...more
With the rise in state legislative efforts to require labeling for foods produced using genetic engineering or “GMOs,” the Grocery Manufacturers Association (GMA) is poised to enter the labeling debate by working with federal...more
Attorney David Lagasse, Member of Mintz Levin's Employment, Labor & Benefits Practice, talks about potential pitfalls that start-ups should be aware of when designing their compensation programs....more
Attorney David Lagasse, Member of Mintz Levin's Employment, Labor & Benefits Practice, talks about the use of an earn-out arrangement as a way to resolve disagreements between buyers and sellers regarding the value of a...more
On September 25, 2013, the Food and Drug Administration (FDA) issued final guidance on Mobile Medical Applications – healthcare related software applications intended for use on mobile platforms such as smartphones and...more
On July 15, 2013, the U.S. Food and Drug Administration (FDA) released proposed rules implementing sections of the Food and Drug Administration Safety and Innovation Act (FDASIA) and the FDA's new authority to protect the...more
The United States District Court for the District of Columbia issued an opinion in Ivy Sports Medicine, Inc. v. Sebelius, a lawsuit filed in May 2011 by ReGen Biologics, Inc. (“ReGen”) against the Food and Drug Administration...more
On February 1, 2013, the Centers for Medicare & Medicaid Services (CMS) published long-awaited rules (the "Rules") detailing manufacturers' and group purchasing organizations' reporting requirements under Section 6002 of the...more
The Obama Administration issued a Report earlier this month, entitled "Administration Strategy on Mitigating the Theft of U.S. Trade Secrets," that sets forth its efforts to prevent trade secret misappropriation. The Report...more
The Small Business Administration (SBA) recently amended the rules relating to its Small Business Innovation Research (SBIR) program and Small Business Technology Transfer (STTR) program. The new SBA rules implement the...more
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