Topic: FDA

JD Supra Corporate Brief: Prohibited Persons, Conflict Minerals, Food Labels, Frequent Flyers

Looking for the latest business law news? Look no further: As many as 50,000 names of “prohibited persons” are included on the US, UK, EU, and UN sanctions lists… (Michael Volkov) The CFTC’s new guidance on how Dodd-Frank Act requirements will apply to cross-border swap activities is the agency’s most complicated undertaking in the past… Read more »

JD Supra Corporate Brief: China Detentions, HIPAA Policies, Compounding Pharmacies, Club Deals

Sign up for email delivery of the JD Supra Corporate Brief, and you’ll never go hungry for reading material again! The key lesson for multinationals from China’s arrest and detention of four GSK employees? Update your anti-corruption programs… (K&L Gates) Worried that the Supreme Court’s ruling against “pay to delay” agreements in Actavis could expose… Read more »

JD Supra Corporate Brief: HSR Compliance, WTO Disputes, NLRB Appointees, FERC Fines

This Friday? Iced coffee to go with your JD Supra Corporate Brief. And no need to heat up that scone… Awesome video: assignment in a merger / change of control, by Richard Hsu (Shearman & Sterling) Those Hart-Scott-Rodino reporting requirements? Turns out the feds are serious about compliance… (Morrison & Foerster) Less than one year… Read more »

JD Supra Corporate Brief: Immigration Reform, Insider Trading, Cyber Insurance, Caffeine Fix

Briefcase? Check. Coffee? Check. JD Supra Corporate Brief? Check. Let the commute begin! The draft “Gang of Eight” immigration bill proposes higher limits on foreign workers in exchange for more regulation of employers (but that’s not all…) (Franczek Radelet) Should insider traders be punished for their actions, or for the profits they made through the… Read more »

Doing Business in China: Latest Need-to-Know from JD Supra

For your convenience, here’s a roundup of recent legal commentary and analysis on a broad range of issues facing companies doing business in and with China, on data privacy and protection, merger control regulations, employment law, intellectual property, corruption, and more: Chinese Ministry of Industry and Information Technology Issues Draft Provisions Governing Protection of Personal… Read more »

Off-Label Marketing Opinion Sends Warning to Pharmaceutical Companies

“The Ninth Circuit has reopened a door for off-label marketing prosecutions, and it is important to review your compliance and risk management programs in light of this recent decision.” (Sheppard Mullin) Earlier this month, the Ninth Circuit issued an opinion that sends an important warning to pharmaceutical manufacturers: the First Amendment doesn’t protect off-label marketing… Read more »

Off-Label Marketing Conviction Violates First Amendment

“In an opinion that will certainly be welcomed by many in the industry, the court rejected the government’s interpretation of the Food, Drug and Cosmetic Act’s (FDCA) misbranding provisions, holding, ‘We conclude simply that the government cannot prosecute pharmaceutical manufacturers and their representatives under the FDCA for speech promoting the lawful off-label use of an… Read more »

New FDA User Fee Law Includes Biosimilar & Generic Drug Approval Pathways

On July 9, 2012, President Obama signed the Food and Drug Administration Safety and Innovation Act (FDASIA) into law. The new legislation extends through 2017 the FDA’s program of charging user fees on drug applications – used to pay the agency’s employee salaries – in exchange for a quicker and more transparent product review process.… Read more »

FDA Publishes Draft Rules on Biosimilars – Legal Roundup

On February 9, The Food and Drug Administration released its draft guidelines for drug makers on the abbreviated approval pathway for biosimilars, a move that could open the door to cheaper generic versions of branded biotech drugs. For your reference, here’s a roundup of legal commentary on the proposed rules: FDA Publishes Draft Guidelines for… Read more »

FDA Proposes Social Media Guidance on Off-Label Drug Use

It’s estimated that one in five prescriptions treat ailments other than those for which the drug was originally intended. Off-label use of pharmaceuticals and medical devices, as this practice is called, is big business. But for manufacturers seeking to inform the public about the benefits and dangers of using medications off-label, it’s also risky business: while… Read more »

Mobile Medical App? There’s an FDA Draft Guidance For That.

We’re seeing interest in the Food and Drug Administration’s Draft Guidance, issued July 21, 2011, on the regulation of mobile medical applications which, according to the FDA, pose similar risks as other regulated medical devices.  We’ll continue to update this reading list as additional commentary and analysis comes in: Draft Guidance Clarifies How FDA Plans… Read more »