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FDA Announces Dates for Long-Awaited Public Hearing on Its Regulation of Off-Label Communications

Times, They Are A-Changin’ - On Wednesday, FDA announced that it will hold a two-day public hearing on November 9th and 10th to obtain input from a broad cross-section of the health care industry, including...more

"Privacy & Cybersecurity Update - August 2016"

In this edition of our Privacy & Cybersecurity Update, we highlight guidance issued by the Irish data protection authority regarding the use of location data, as well as the FTC's request for comment on its Standards for...more

Settle or Fight FDA/DOJ Off-Label Use Allegations? WSJ Editorial Looks at Vascular Solutions Trial Win and Asks What's Next?

In an editorial this weekend entitled “No Justice for Business,” The Wall Street Journal hailed a recent trial win by medical device maker Vascular Solutions, Inc. (VSI) as a “victory for common sense and the First Amendment”...more

Virginia’s Certificate of Need Laws May Stay, Fourth Circuit Says

On January 21, the U.S. Court of Appeals for the Fourth Circuit upheld Virginia’s Certificate of Need (CON) laws, ruling that the scheme does not illegally discriminate against out-of-state health care providers. See Colon...more

Ruling on Economic Favoritism Puts ‘NC Dental’ Back in Spotlight

In a recent opinion, a divided panel of the U.S. Court of Appeals for the Second Circuit ruled that an economic regulation passed by a state agency solely to protect one group from competition would not violate the...more

One Small Step for Amarin & One Giant Leap for Pharmaceutical Companies? - Only Time Will Tell

Friday’s ruling in Amarin Pharma, Inc. v. United States Food & Drug Administration is a monumental event. It signals the dawn of a new era for prescription drug promotion....more

US District Court for the District of New Jersey Dismisses Data Breach Class Action on Lack of Article III Standing

In re Horizon Healthcare Services, Inc. Data Breach Litigation was a class action law suit arising out of the theft of two of Horizon’s password-protected laptops that contained the personal information of more than 839,000...more

The 'Palmetto Put-Down' Endangers Drug Cos. Nationwide

On Feb. 25, 2015, nearly two years after argument, the South Carolina Supreme Court directed entry of a $136 million judgment against Janssen Pharmaceuticals Inc. These civil penalties stemmed from a suit brought by the...more

FDA Proposed Rule in Flux?

On Tuesday, the U.S. Food and Drug Administration (FDA) announced that it has reopened the comment period for its proposed rule on generic drug labeling. It has also scheduled a day-long public meeting to hear comments and...more

Is Off-Label Drug Promotion Protected Free Speech?

It is a very common practice. Drug sales reps visit a client, usually a hospital, a clinic or a doctor, with the sole purpose of selling a drug or medical device. That is the primary way a doctor learns about a drug or...more

Un test sulle ipotesi delle proiezioni a medio-lungo termine della spesa farmaceutica

We use the same methodology, that Ecofin-Oecd apply for projecting expenditure in the medium-long term, to reconstruct expenditure in the medium-long past. It is possible to compare the effective expenditure with the...more

NFLPA Investigates Buccaneers on MRSA Issue

NFLPA Investigates Buccaneers on MRSA Issue by Anthony Caruso on September 11, 2013 The Tampa Bay Buccaneers may be in hot water over whether the team communicated the outbreak of MRSA - a dangerous bacteria resistant...more

Second Circuit Vacates Misbranding Conviction for Pharmaceutical Representative on First Amendment Grounds

In United States v. Caronia, No. 09-5006-cr, slip op. (2d Cir. Dec. 3, 2012), the U.S. Court of Appeals for the Second Circuit held that "the government cannot prosecute pharmaceutical manufacturers and their representatives...more

Lo sviluppo delle copie economiche dei farmaci off-patent e il bottleneck della distribuzione al dettaglio

Lo sviluppo delle copie economiche dei farmaci off-patent e il bottleneck della distribuzione al dettaglio. Brevi riflessioni sull'Italia...more

Le farmacie nel Diritto dell'Economia

Nel dibattito che accompagna i tentativi di riforma degli esercizi farmaceutici e della distribuzione del farmaco si continua, in maniera pretestuosa, a far riferimento a un presunto contrasto tra da un lato le indicazioni...more

Commento di Nicola ad articolo di Luisa Grion su la Repubblica

Il copay che può far bene alal sanità e al Federalismo (di Nicola C. Salerno) data = 20 Dicembre 2010...more

La regolamentazione delle farmacie in Italia (Fabio Pammolli e Nicola C. Salerno, CeRM, 12 Novembre 2010)

All’indomani dell’audizione del Presidente dell’Agcm Antonio Catricalà in Commissione Igiene e Sanità del Senato, questo Wp fa il punto sullo stato della distribuzione al dettaglio del farmaco...more

Farmacie, distribuzione del farmaco e sentenze della Corte Costituzionale e della Corte di Giustizia Europea - NICOLA C. SALERNO

Nel dibattito che accompagna i tentativi di riforma degli esercizi farmaceutici e della distribuzione del farmaco, si è aggiunto, negli ultimi tempi, un argomento nuovo. Un presunto contrasto tra da un lato le...more

An Ad Hoc Inquiry Into the Feasibilities and Impracticalities Associated With Class Certification Of Blood Glucose Monitor Users

Recent developments in pre-emption law have outlined the requirements for bringing an action against a manufacturer of an FDA approved medical device. Specifically, devices that undergo the 510(k) approval process remain a...more

IMS v. Ayotte, A.G., State of NH

DecisionNot Applicable

Court Upholds New Hampshire Prescription Privacy Law. Today, the First Circuit Court of Appeals upheld a New Hampshire law that bans the sale of prescriber-identifiable prescription drug data for marketing purposes. In...more

IMS v. Rowe, A.G., State of Maine

Amended Order on Plaintiffs' Motion For Preliminary InjunctionMaine

Maine Prescription Privacy Law Struck Down. In IMS v. Rowe, the Maine federal district court held that the state prescription privacy law violated the First Amendment. The court held that the Act improperly restricted the...more

IMS v. Ayotte, A.G., State of NH

Supplemental Brief for the Electronic Privacy Information Center as Amicus Curiae and 16 Experts in Privacy Law & Technology in...Not Applicable

EPIC Urges Court to Consider Privacy Interest in De-Identified Patient Data. EPIC and 16 experts in privacy and technology today filed a "friend of the court" brief in a case concerning a New Hampshire state law banning...more

IMS v. Ayotte, A.G., State of NH

Brief of Kelly A. Ayotte, Attorney General of New HampshireNot Applicable

New Hampshire Files Brief in First Circuit Appeal of Ayotte. New Hampshire has filed its brief in the First Circuit Court of Appeals seeking reversal of the federal district court's decision striking down the state...more

IMS v. Ayotte, A.G., State of NH

Memorandum and OrderNew Hampshire

New Hampshire Prescription Privacy Law Struck Down. In IMS v. Ayotte, the New Hampshire federal district court held that the state Prescription Confidentiality Act violated the First Amendment. The court held that the Act...more

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