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Fate of legalized cannabis hinges on key vote

On Thursday, March 22, U.S. Congress will vote on the most recent omnibus spending bill, allocating the funds approved by President Trump when he signed a budget deal on February 8, 2018. Since 2014, every such spending bill...more

Despite political uncertainty, Illinois judge orders expansion of medical cannabis

A recent Illinois court decision involving medical cannabis is a perfect example of the growing chasm between federal and state regulation. In the wake of U.S. Attorney General Jeff Sessions revoking the Cole Memorandum in...more

FDA to step up enforcement of homeopathic medicine

Homeopathic medicine has long occupied a niche in American culture. Since 1988, with the issuance of the Compliance Policy Guide, § 400.400, “Conditions Under Which Homeopathic Drugs May be Marketed,” the FDA has had a...more

Recreational marijuana shake-up: Sessions revokes Cole Memorandum

Yesterday, Jan. 4, 2018 – just four days after recreational cannabis became legal in California – Attorney General Jeff Sessions rescinded the long-standing “Cole Memorandum” issued in 2013 by Deputy Attorney General James M....more

Will big beverage, Canadian legislation tilt U.S. closer to federal legalization?

On Oct. 30, 2017, Constellation Brands, a global Fortune 500 producer and marketer of beer, wine and spirits, announced a collaboration with Canopy Growth, a provider of medical cannabis products. The collaboration is...more

Clinical trials Part I: The upcoming clinical trials reporting rule

In 2007, Congress passed the “Food and Drug Administration Amendments Act of 2007,” the purpose of which was, in part, to update the FDA’s rules surrounding clinical trials. The FDA took nearly a decade to review the law,...more

The FDA's new Digital Health Plan

The US Federal Food and Drug Administration (‘FDA’ or ‘Agency’) Commissioner Dr Scott Gottlieb has used an FDA blog post to announce plans for a new digital health devices initiative, specifically the initiative’s Digital...more

FDA’s Health Software PreCert program to fast-track innovation

Digital information has taken over our day-to-day lives, and the federal Food and Drug Administration (FDA) continues to recognize that this includes many aspects of our health care as well. This is clearly demonstrated by...more

AG Sessions seeks repeal of Rohrabacher-Farr Amendment

Since the new Presidential administration took office late last year, the cannabis industry has received a mixed set of signals from this administration as to how it will treat the growing cannabis industry in relation to the...more

FSVP compliance dates arrive, challenges to food industry increase

On May 30, 2017, the FDA’s Foreign Supplier Verification Programs (FSVP) for Importers of Food for Humans and Animals went into effect, placing new compliance requirements on food importers. As readers will recall, in 2011,...more

Interpreting the renewed Rohrabacher-Farr Amendment: A loophole for enforcement?

In 2013, the U.S. federal government shut down while federal legislators debated about various political issues of the year. However, during that debate, an amendment was added to the final spending bill that stated as...more

Privacy and the Internet of Medical Things: What’s a curmudgeon to do?

One of the authors of this piece uses a medical device that is wirelessly networked to the device’s vendor. The author recently received a text message from the vendor, sending “congratulations” for using the device for an...more

FDA sanitary transport rule impacts railroads, other shippers

The Food and Drug Administration’s new Sanitary Transport of Human and Animal Food Rule takes effect on April 6, 2017, imposing new rigorous food safety regulations on food shippers – including railroads – and creating a...more

DEA awards Schedule II classification to synthetic THC drug

On March 23, 2017, the DEA announced it has scheduled the newly approved synthetic THC-containing drug, Syndros, as a Class II substance. This announcement comes as a surprise to some for a number of reasons, including that...more

AG's latest remarks signal no outright campaign against cannabis yet

On March 2, 2017, it seemed as if the U.S. Department of Justice was aiming to crack down on the U.S. cannabis industry in a way not seen since before the previous administration. U.S. Attorney General Jeff Sessions and White...more

The end of legalized recreational cannabis under President Trump?

Ever since President Trump took office, the cannabis industry has been holding its breath to see how the new administration would handle the burgeoning industry. Trump’s previous statements about cannabis have been mixed,...more

Food industry sees one of first whistleblower suits under FSMA

As part of the massive overhaul of food safety regulations under the Food Safety Modernization Act, Life Sciences Decoded reported in August on new whistleblower protections for food industry employees. On Feb. 9, six months...more

Food contact goods and the FSVP: Deciphering the FDA’s stance

The last 18 months have seen a flurry of regulatory activity as the FDA has finalized and begun enforcing a number of new regulations based on the Food Safety Modernization Act (FSMA). Among these regulatory schemes is the...more

FDA bans powdered gloves in human, animal medicine

Effective Jan. 18, 2017, the federal Food and Drug Administration has, by implementation of a final rule, banned the use of powdered gloves by a physician when treating humans or animals. Powdered gloves are now added to the...more

Cannabis in animal supplements: A hazy proposition

Over at our Life Sciences Decoded blog, we have discussed the state of limbo in which animal dietary supplements exist from a regulatory perspective. In the case of human products, foods, dietary supplements and drugs occupy...more

What the FDA has in store for the food industry in 2017

As Life Sciences Decoded looks forward in 2017, it is clear that FDA-regulated industries have a great deal of change confronting them. Last year, 2016, was a landmark year for the FDA and food regulations, as the agency...more

Is the FSMA a plaintiff’s lawyer’s dream and the food industry’s nightmare?

The Food Safety Modernization Act (FSMA) became law in 2011, signaling a sea change in U.S. food safety regulation and making prevention the cornerstone of safety measures. To achieve its lofty goals, while providing time for...more

Election results widen gulf between federal v. state regulation of cannabis

Legal cannabis programs continue to spread to more states with every election cycle. On Nov. 8, 2016, Arkansas, Florida, Montana and North Dakota passed laws legalizing cannabis for medical uses, while California, Nevada,...more

The new look of FDA food facility registration: Human and animal food companies beware

The food industry has long been familiar with the requirement that facilities involved in the handling, packing, holding, storing, manufacturing or other processing of food must register with the Food and Drug Administration....more

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