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The FDA’s Informed Consent Draft Guidance: Insights and Challenges for IRBs, Clinical Investigators and Sponsors

On July 15, 2014, the FDA released a draft guidance document (“Guidance”), proposing recommendations to Institutional Review Boards (IRBs), clinical investigators and research sponsors relating to the informed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

"FDA Guidance Limits Flexibility in Social Media Promotional Communications"

Three recently issued draft guidance documents (Draft Guidances) from the U.S. Food and Drug Administration (FDA or Agency) are designed to assist manufacturers in product communications via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

Division of Tax Appeals Rules Patent License Fees Not Subject to Sales Tax in New York

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

EPA’s Enforcement Efforts Regarding FIFRA Supplemental Distribution and How to Avoid Noncompliance

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

Protecting Drug Supply Chain Security

Millions of Americans take prescription drugs every day while assuming that those drugs are what they purport to be, that they have not been tampered with, and certainly that they are not counterfeit. The validity of those...more

Generic Drug Company Licensees Avoid Patented Medicines Price Oversight

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

The FAA’s “Regulations” Pertaining to Unmanned Aircraft Systems

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

FDA Draft Guidance Proposes Change to Combination Product Exclusivity Policy

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 In draft guidance released by the Food and Drug Administration (FDA or the Agency) on February 24, 2014, the Agency proposed changes to its...more

FDA Intends to Grant Five Years of Market Exclusivity to Fixed-Dose Combination Drugs Containing One New Drug Substance

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

FDA Issues Draft Guidance on Custom Devices

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

FDA’s Final Guidance Distinguishes Liquid Dietary Supplements from Beverages

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

FDA Issues Draft Guidance Relating to Social Media Promotion by Drug and Biologics Manufacturers

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

Industry Group To Weigh In On GMO Labeling Debate

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

Structuring Compensation Programs – Interview with David Lagasse, Member, Mintz Levin [Video]

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

Earn-Out Arrangements – Interview with David Lagasse, Member, Mintz Levin [Video]

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

FDA Finalizes Guidance on "Mobile Medical Applications"

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

FDA Issues Proposed Rules That Give FDA Administrative Detention Authority with Respect to Drugs

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

FDA 510(k) Rescission Authority Upheld - U.S. District Court Finds for FDA in ReGen Litigation

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

Research-Related Payments and the Physician Payment Sunshine Act: How Reporting Works and What Applicable Manufacturers Should...

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

Obama Administration Reports on Efforts to Prevent Trade Secret Misappropriation

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

SBA Rules: Investment Funds Can Now Be Majority Owners of SBIR Companies

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

EU Proposed Directive on Network and Information Security

On 7 February, the European Commission (EC) published an EU Cyber Security Strategy encompassing a proposed Directive on Network and Information Security (NIS Directive). The aim of the Strategy and NIS Directive is to...more

FDA Issues Final Rule Regarding CGMPs for Combination Products

On Tuesday, January 22, 2013, the United States Food and Drug Administration (FDA or “the Agency”) published a final rule regarding Current Good Manufacturing Practice Requirements for Combination Products. 78 Fed. Reg. 4307...more

Recent Privacy Developments: California AG Continues to Lead on Mobile with New Recommendations and FTC Amends COPPA

Nearly all businesses today are involved in some way in the development or distribution of mobile applications. The first part of this Client Alert highlights recent activities of the California State Attorney General to...more

DOE Grant For Superconducting Wires

Lapeer-based Grid Logic has been awarded a $3.8 Million grant from the Department of Energy to develop a low-cost superconducting wire for use by electric utilities. This funding, under the Advanced Research Project Agency...more

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