News & Analysis as of

Over-the-Counter Sales

Senate Passes Long-Awaited FDA User Fee Package

Following nearly two years of negotiations and hearings examining the Generic Drug User Fee Amendments (GDUFA) and the Biosimilar User Fee Act (BsUFA), the Prescription Drug User Fee Act (PDUFA) and the Medical Device User...more

Southern District of Illinois Excludes Plaintiff’s Experts in OTC NSAID Kidney Injury Case

by Reed Smith on

Next week, we are traveling to Budapest, with a side trip to Vienna. We are visiting the Drug and Device Law Rock Climber, who is spending this semester abroad studying computer science (in Budapest) and climbing rocks (in...more

Japanese Variation Margin Requirements Take Effect

by Jones Day on

Following the Basel Committee on Banking Supervision and the International Organization of Securities Commissions' March 18, 2015, release of revisions to the framework for margin requirements for non-centrally cleared...more

The Future of the Affordable Care Act Week 7: The American Health Care Act

On March 6, 2017, after years of promising, GOP lawmakers in the House of Representatives introduced the “American Health Care Act” (AHCA), the first concrete legislative proposal detailing the initial provisions designed to...more

What Is “Product Liability”?

by Reed Smith on

We’re serious – we’re not planning to give a flip answer like “an extortion racket.” No, it’s more like law school, where a first-year contracts professor began with the question “What is Chicken?” (Hint – that’s discussed...more

A&B Healthcare Week in Review

by Alston & Bird on

On January 9, 2017, the Food and Drug Administration (FDA) issued a draft guidance entitled, Annual Reporting by Prescription Drug Wholesale Distributors and Third-Party Logistics Providers: Questions and Answers; Draft...more

Implied Preemption and Monograph Drugs

by Reed Smith on

The Reed Smith blogging team has just returned from this year’s annual ACI Drug & Medical Device Litigation conference. In addition to excessive amounts of eating, drinking, and socializing (now called “networking”), we kept...more

Hearing Aid Deregulation to Affect Wireless Device Industry and Create Compatibility Issues

by Saul Ewing LLP on

Within the last week, both the U.S. Senate and the U.S. Food and Drug Administration (FDA or the Agency) have taken significant steps to deregulate a large portion of hearing aid devices. Despite the benefits that hearing...more

FTC Issues Long-Awaited Enforcement Policy on OTC Homeopathic Drugs

We reported a few weeks ago about a new warning from FDA related to the safety of certain teething-related, non-prescription homeopathic drug products, and in that post we mentioned that both FDA and the Federal Trade...more

FDA Drops 19 Ingredients From the OTC Antibacterial Monograph: Antibacterial and Hand Soap Manufacturers Have One Year to Comply.

by Locke Lord LLP on

On September 6, 2016, the Food and Drug Administration (FDA) published a final rule on the use of certain active ingredients which were proposed for inclusion in the Over-The-Counter (OTC) Consumer antiseptic washes portion...more

California Federal Court Holds That U.S. Securities Laws Do Not Apply to Unsponsored, Unlisted ADRs

by Proskauer Rose LLP on

The U.S. District Court for the Central District of California held on May 20, 2016 that the federal securities laws do not apply to U.S. transactions in unlisted, unsponsored American Depositary Receipts (ADRs) for a foreign...more

Silence Would Have Been Golden: Unnecessary Illogical Preemption Decision in Motrin SJS/TENS Summary Judgment Victory

by Reed Smith on

We sat through The Revenant again this weekend, at the plaintive (not plaintiff) request of a Drug and Device Law Friend who had yet to see it. Last time, we barely stayed awake. This time, we lost the battle. We have heard...more

More Money May Be in Store for Distilleries

by Williams Mullen on

More favorable changes may be in store for distilleries that want to sell bottles on-premise to consumers in North Carolina. Proposed new North Carolina legislation would (1) expand the number of distilleries that can sell...more

Hedging Oil & Gas Production

by Jackson Walker on

The recent, dramatic decline in the price of oil illustrates the risk that every oil and gas producer has to declining energy commodity prices. This paper discusses various methods for “hedging” or reducing price risk. In...more

SEC Remarks at the Practising Law Institute’s Program Titled “SEC Speaks in 2015”

On February 20, 2015, several representatives from the SEC spoke at the Practising Law Institute’s program titled “SEC Speaks in 2015,” including Chair Mary Jo White and Commissioner Louis A. Aguilar. Ms. White provided...more

Additional Two-Year Clearing Reprieve for European Pension Schemes

The European Commission (EC) has proposed a further two-year extension beyond the three-year exemption from mandatory clearing of over-the-counter derivatives granted to qualifying pension scheme arrangements (PSAs) under...more

OTC Derivatives Regulators Issue Report Regarding Cross-Border Issues

On September 10, the Over-the-Counter Derivatives Regulators Group (ODRG) issued a report providing an update to the Group of 20 (G20) on its progress in resolving over-the-counter (OTC) derivatives cross-border...more

IOSCO Launches Public Information Repository for Central Clearing Requirements

On August 5, IOSCO unveiled its new information repository for central clearing requirements relating to over the counter derivatives....more

ERISA (8th Circuit): Over-The-Counter Vitamin Supplements Trigger Pre-Existing Condition Exclusion

What sort of “medical treatment” triggers the pre-existing condition exclusion in an ERISA-governed disability policy?...more

FINRA Proposes to Adopt Rules on Quotation Requirements for OTC Equity Securities

The Financial Industry Regulatory Authority, Inc. is proposing to adopt rules governing the quotation requirements applicable to over-the-counter (OTC) equity securities. The rules would establish minimum standards for...more

Microcap Fraud: An FBI Controlled Shell Company

by Dorsey & Whitney LLP on

Five men came together to plan the manipulation of an over-the-counter traded shell. What they did not know was that the shell was controlled by the FBI. SEC v. Affa, Civil Action No. 1:14-cv-12959 (D. Mass. Filed July 11,...more

Planes, trains and Over-the-Counter pills

by Reed Smith on

This Reed Smith client alert looks at the recent amendments to the Human Medicines Regulations 2012, which came into force in November 2013....more

Health Reform + Related Health Policy News - July 2013

by Polsinelli on

In This Issue: - Top News ..Obama Administration Delays Employer Mandate One Year ..House Energy and Commerce Committee Releases Draft Legislation for SGR Fix ..CMS Proposes Payment Changes for Medicare...more

23 Results
|
View per page
Page: of 1
Cybersecurity

"My best business intelligence,
in one easy email…"

Your first step to building a free, personalized, morning email brief covering pertinent authors and topics on JD Supra:
Sign up using*

Already signed up? Log in here

*By using the service, you signify your acceptance of JD Supra's Privacy Policy.
*With LinkedIn, you don't need to create a separate login to manage your free JD Supra account, and we can make suggestions based on your needs and interests. We will not post anything on LinkedIn in your name. Or, sign up using your email address.