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Prescription Drugs Electronically Stored Information

Husch Blackwell LLP

What to Learn From DOJ’s First Telehealth-Prescribed Controlled Substances Case

Husch Blackwell LLP on

On June 13, 2024, the Justice Department announced arrests in what it called the nation’s first criminal case against digital health company executives over allegations that those executives caused illegal prescriptions for...more

Hanzo

Complying With the FDA’s Advertising Regulations: Why You Need an Interactive Website Archive

Hanzo on

Pharmaceutical advertising is big business. In 2020, pharmaceutical companies spent more than $6.5 billion on advertising. The Food and Drug Administration (FDA) regulates advertisements of prescription drugs, but it...more

Dorsey & Whitney LLP

District of New Jersey Rules Prescription Drug Events Tainted By Alleged Kickback Schemes Constitute False Claims

Dorsey & Whitney LLP on

A federal judge recently ruled that submission of electronic data to the government can, under appropriate circumstances, give rise to liability under the False Claims Act. In U.S. ex rel. Marc Silver et al. v. Omnicare Inc....more

Searcy Denney Scarola Barnhart & Shipley

Viagra — Developments in Litigation

There have been some very recent developments in the national litigation regarding the erectile dysfunction (ED) drug Viagra and the allegation that its use increases a patient’s risk of developing melanoma. Judge Seeborg,...more

Cozen O'Connor

Going Paperless: FDA Releases Draft Guidelines to Digitize Clinical Trials

Cozen O'Connor on

The FDA released draft guidelines (“Guidelines”) on Monday, March 9, 2015 establishing recommendations on the use of e-media and processes to obtain informed consent for clinical investigations (trials) of medical products...more

BakerHostetler

FDA Proposes Electronic Distribution of Prescribing Information

BakerHostetler on

Drug manufacturers may no longer be required to distribute prescribing information on paper—with limited exceptions—and instead may have to distribute that same information electronically. The FDA recently issued a proposed...more

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