Topic: FDA

JD Supra Corporate Brief: Big Data, Green Trade, iPad Regulation, Ukraine Sanctions

On March 11, 1999, Infosys became the first Indian company to be listed on the NASDAQ stock exchange. Mo’ data mo problems… (Judy Selby at BakerHostetler) Going green + going global = going great! (King & Spalding) When is an iPad more than an iPad? When it’s an FDA regulated medical device, for starters… (Sharon… Read more »

FDA Proposes New Policy to Boost Development of Fixed-Combination Drug Products

“FDA’s new interpretation of these terms would result in a determination of 5-year [New Chemical Entity] exclusivity for each active ingredient in a drug product instead of the drug product as a whole.”  (Carlson Caspers) The Food and Drug Administration has proposed a policy change that should give combination therapies a shot in the arm.… Read more »

JD Supra Corporate Brief: Tax Reform, Proxy Season, Drug Labels, Internal Investigations

Happy birthday, AT&T! On this day in 1885, the American Telephone and Telegraph Company is incorporated in New York State. Representative Camp says his reform plan will make the tax code simpler and fairer, spur economic growth, and create jobs. What do you say? (Evan Migdail and Bruce Thompson at DLA Piper) Bundling? Unbundling? Why… Read more »

JD Supra Corporate Brief: Artificial Intelligence, Cybersecurity Framework, Safe Harbor, LIBOR Administrator

On this day in 1801, an electoral college tie was resolved when the House of Representatives named Thomas Jefferson President of the United States, and Aaron Burr Vice-President. Anybody else think that would have been an interesting outcome for the Bush v. Gore election? Robotics, artificial intelligence, and automation are transforming the workplace. So what… Read more »

JD Supra Corporate Brief: Proxy Guidance, Whistleblower Tips, Legalized Marijuana, DOL Investigations

Email delivery of the JD Supra Corporate Brief is the new black. It’s that time of the year again. And this 230-page guide has everything you need for a successful proxy season… (Morrison & Foerster) Employers should consider specialized insurance for responding to the dramatic increase in wage and hour lawsuits… (Kami Quinn and Jason… Read more »

JD Supra Corporate Brief: Retail Cybersecurity, Striking Workers, Snow Days, Transfer Pricing

On February 4, 1801, John Marshall is sworn in as Chief Justice of the United States. Could Bitcoin make retail cybersecurity obsolete? (Henry Dinger, Grant Fondo, and William Stern; JD Supra Perspectives) Employers, you need to read these Affordable Care Act updates… (JD Supra Contributors) There’s a lot at stake for the NLRB in its… Read more »

JD Supra Corporate Brief: State of the Union, Regulating the Insurance Industry, Tilting at Windmills, Reforming Corporate Taxes

And the rest is history: on this day in 1886, Karl Benz patented the first successful gasoline-powered automobile. President Obama’s 2014 State of the Union address: the JD Supra reader… (JD Supra Contributors) Here’s a look at the top regulatory issues for the insurance industry in 2014… (Chris Mosley, Hilary Rowen, and Matthew Vuolo; JD… Read more »

FDA Sets Out to Fight Food Terrorism with New Rule: 3 Takeaways for Food Facilities

“[T]he rules would provide an uncertain level of protection from an admittedly very unlikely occurrence, at a significant cost to industry.” (John Moore of Venable) Late last year, the Food and Drug Administration announced that it was joining the fight against terrorism with a new rule aimed at protected food from intentional contamination. The background,… Read more »

JD Supra Corporate Brief: Supply Chain Security, Safe Harbor Program, Iran Sanctions Changes, California Fracking Rules

On December 2, 2001, Enron filed for Chapter 11 bankruptcy. Can you believe it’s been just twelve years? What do changes to US sanctions on Iran mean for American companies? (Perkins Coie) Supply chain security compliance just got a lot harder for Department of Defense contractors… (Peter McLaughlin, Rick Vacura, and Bradley Wine at Morrison… Read more »

JD Supra Corporate Brief: Stopping 23andMe Sales, Buying Privacy Liabilities, Changing Proxy Policies, Approving REIT Conversions

On November 27, 1924, the very first Macy’s Thanksgiving Day parade was held. As it should be… Happy Holidays! The FDA is routinely criticized in cases where regulation is perceived to stymy innovation. Shutting down 23andMe isn’t one of them… (Andrew Ittleman and Kelly Lightfoot, JD Supra Perspectives) Every mobile app that glitters is not… Read more »

FDA’s Proposed Rule on Generic Drug Labeling Could Sow Confusion and Chaos (and Lawsuits)

The FDA wants to give generic drug makers the same labeling authority as their branded peers. Attorneys Erin Bosman, James Huston, and Julie Park of Morrison & Foerster explain: [T]he U.S. Food and Drug Administration (FDA) published a long-awaited proposed rule … in an effort to ‘create parity’ between brand-name and generic manufacturers for their… Read more »

JD Supra Corporate Brief: Executive Salaries, Government Shutdown, Accounting Fraud, Chinese IPOs

Sign up for email delivery of the JD Supra Corporate Brief, and get a puppy! OK, there’s no puppy – but there is still great law news in your inbox every weekday morning! Are Chinese anti-corruption authorities turning up the heat on investigation and information-gathering firms? (McDermott Will & Emery) Just how much influence do… Read more »

JD Supra Corporate Brief: Health Care Enforcement, Web Privacy Policies, GMO Food Labels, Green Chemistry Rules

Why yes, I would love to get the JD Supra Corporate Brief delivered straight to my inbox. Where do I sign up? Whistleblowers are driving stepped up government health care enforcement… (Mintz Levin) Study finds about half of companies worldwide fail to comply with web privacy policy requirements… (Pillsbury) What does the EU’s Alternative Investment… Read more »

Botnets, Cyber Weapon Controls, White House Incentives, and More – What We’re Reading in Cybersecurity Now

Here’s a quick look at what’s grabbing our attention right now on JD Supra. Recent updates on the myriad risks, concerns, and legal developments around cybersecurity and data protection: White House Posts Preliminary Cybersecurity Incentives (Proskauer): “On August 6, 2013 the White House posted its preliminary list of incentives encouraging the adoption of cybersecurity best… Read more »

JD Supra Corporate Brief: White House, Unauthorized IP, Stem Cells, Broadcast TV

Stop right there: on this day in 1914, the first electric traffic light was installed in Cleveland, Ohio… The White House has to act quickly to correct a recent “dangerous” ruling from the ITC on standard-essential patents… (Orrick) Unauthorized IP in your supply chain can be costly… (White & Case) The OECD wants to change… Read more »