In April of this year, the US Food and Drug Administration (FDA) released a discussion paper, Proposed Regulatory Framework for Modifications to Artificial Intelligence/Machine Learning (AI/ML) – Based Software as a Medical Device (SaMD), which proposed a novel regulatory framework for artificial intelligence (AI)-based medical devices. The public docket closed on June 3, 2019, and FDA received over one hundred comments from manufacturers, industry associations, and other interested parties. The comments vary in support of FDA’s framework and largely urge FDA to align with external stakeholders that are already developing industry standards and clarify the agency’s expectations under the proposed framework. Continue Reading
*This article was originally posted in Law360 on June 4, 2019.
The much-anticipated public hearing last week at the U.S. Food and Drug Administration on cannabis and cannabis-derived compounds drew a wide audience of participants, with strong views on how the FDA should (or should not) regulate the controversial plant.
In an amazingly short period of time, hemp-derived products, including those containing cannabidiol, have moved from the fringe to the mainstream, from state-licensed dispensaries to traditional brick-and-mortar retailers. And yet, the FDA’s position has been clear — it is illegal to sell human food, pet food, dietary supplements and unapproved drugs that contain CBD. Continue Reading
The Office of Pharmaceutical Quality (OPQ) in the Center for Drug Evaluation and Research (CDER) within the US Food and drug Administration (FDA) published its annual “Report on the Sate of Pharmaceutical Quality” last week. The yearly report reviews the quality of drug products during the prior year, as measured by recall and product defect information, site inspections of manufacturers, and other post market data. The report provides a few insights that companies may want to consider when working with, or acquiring, contract manufacturers. Continue Reading
On May 1, 2019, AAFCO provided updated guidelines regarding the use of hemp in animal food, including how this market is affected by the Agricultural Improvement Act of 2018 (the “Farm Bill”). Although the AAFCO is not a government agency, its members are government agencies that represent the 50 states, the US Food and Drug Administration (FDA) Center for Veterinary Medicine, and the Canadian Food Inspection Agency. Continue Reading
In an April 4, 2019 Press Release, the U.S. Food and Drug Administration (FDA) announced its issuance of a Warning Letter to Inova Genomics Laboratory (Inova) in Virginia for marketing genetic tests for predicting medication response and patient receptivity to drugs (among other things). FDA identified three genetic tests, including one called “MediMap Plus,” which was designed to provide insight into how a patient would respond to drugs used for anesthesia, cancers, infections, attention-deficit/hyperactivity disorder, depression, anxiety, and diabetes. FDA deemed the tests to be adulterated and misbranded because Inova had not sought premarket clearance. Continue Reading
Norman E. (Ned) Sharpless, M.D., recently took the helm as Acting Commissioner of the US Food and Drug Administration (FDA). Dr. Sharpless most recently served as the director of the National Cancer Institute, part of the National Institutes of Health (NIH), which serves as the government’s principal agency for cancer research. Dr. Sharpless’s appointment comes on the heels of the resignation of former Commissioner Scott Gottlieb, M.D. on April 5, 2019. Continue Reading
While the legal landscape continues to evolve in the cannabis industry, making entry into the space a potentially risky proposition, the passage of the Agriculture Improvement Act of 2018 (the “Farm Bill”) can be a real game changer in attracting mainstream companies to the industry.
According to the Farm Bill, hemp is now exempt from the Federal Controlled Substance Act (“CSA”), theoretically making all hemp-derived cannabidiol (CBD) products, and all commercially available products derived from hemp, legal in all 50 states. Continue Reading
What is Prop 65?
Prop 65 is a California law that requires California consumers receive warnings regarding the presence of chemicals that cause cancer or reproductive toxicity. The law is highly technical, constantly evolving and actively enforced by the government and private enforcers. Continue Reading
After several years of delay, FDA announced this summer that it expects to publish new rules in April 2017 that will permit generic drug companies to make unilateral changes to their warning labels, even if the brand does not. The rule changes, if implemented, would have a significant impact on the potential liability of generic drug manufacturers in product liability cases. The proposed rule changes are being met with significant opposition from trade groups for generic manufacturers.
On July 14, 2016, the House of Representatives passed S.764 creating a National Bioengineered Food Standard. Importantly for food manufacturers and distributors, the law – expected to be signed by President Obama – will preempt all state laws “relating to the labeling or disclosure of whether a food is bioengineered or was developed or produced using bioengineering” if that standard is not identical to the mandatory disclosure under the new federal standard. Once enacted, the law will preempt the Vermont GMO labeling Act that went into effect July 1, 2016.