Regulating E-Cigarettes Remains “Top Priority” For FDA

By Allison Fulton on July 12, 2019 Posted in Tobacco

On July 10, 2019 Ned Sharpless, M.D., the Acting Commissioner of the Food and Drug Administration (FDA) issued a statement reaffirming FDA’s commitment to overseeing the manufacturing, marketing, and sale of e-cigarettes. The statement outlined FDA’s current and anticipated regulation of e-cigarettes, and discussed the balance of keeping e-cigarettes out of the hands of minors while exploring the potential for e-cigarettes to reduce adult smoking of more harmful tobacco products. Continue Reading

Medical Devices – Artificial Intelligence and Reactions to FDA’s Proposed Oversight

By Allison Fulton on June 25, 2019 Posted in Digital Health & Medical Devices, FDA

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

What We Learned From FDA’s Public Hearing On Cannabis*

By Allison Fulton, Christopher Van Gundy and Sarah Blitz on June 18, 2019 Posted in Food & Dietary Supplements

*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

Location Matters – Manufacturing Insights from FDA’s Annual Report on Drug Quality

By Allison Fulton on May 20, 2019 Posted in Enforcement Actions

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

AAFCO Issues Updated Guidelines Regarding Hemp in Animal Food

By Allison Fulton on May 8, 2019 Posted in Food & Dietary Supplements

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

FDA Issues Warning Letter to Lab Marketing Three Laboratory-Developed Tests

By Allison Fulton and Kenneth Yood on April 22, 2019 Posted in FDA

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

FDA Update: Recent Trends and a New Regime

By Allison Fulton on April 19, 2019 Posted in Miscellaneous

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

The Farm Bill’s Impact on Hemp and CBD – and How Some States are Reacting

By Andrea Cataneo on March 12, 2019 Posted in FDA, IP and Technology Transactions, Miscellaneous, Tobacco

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

WARNING: Prop 65 Has Changed – If Your Product Is Sold In California Or You Do Business In California, Pay Attention

By Whitney Jones Roy and Jeffrey Parker on January 18, 2018 Posted in Miscellaneous

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

Proposed New FDA Labeling Rules Would Result in Increased Generic Drug Product Liability Claims

By Bradley Graveline on October 14, 2016 Posted in FDA

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.

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