FDA


FDA Warns 15 More Companies on CBD
November 26, 2019 | Eric D. Fader | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
On November 25, the U.S. Food and Drug Administration announced the issuance of warning letters to 15 companies that it says are violating the Federal Food, Drug, and Cosmetic Act by selling cannabidiol (CBD) products. The FDA’s views on the recent CBD marketing frenzy have been no secret, as previously discussed here. The FDA also …
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Class Action Claims Reinstated on “Adulterated” Dietary Supplements
November 25, 2019 | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Litigation | Pharmaceuticals
The 11th Circuit Court of Appeals recently reversed a Florida lower court decision that dismissed class action claims under the Florida Deceptive and Unfair Trade Practices Act, the Illinois Consumer Fraud and Deceptive Business Practices Act, and the New York General Business Law alleging that the defendants defrauded the putative class by selling adulterated dietary …
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Shapiro to Present on Nutrition Labeling Regulations for the AHPA
October 23, 2019 | Rivkin Rounds Staff | FDA | Legislation and Public Policy
Steven Shapiro will be a speaker on a webinar offered by the American Herbal Products Association (AHPA) entitled “Compliance with FDA’s Revised Nutrition Labeling Regulations for Herbal Supplements.” Scheduled for October 29 from 1-3 pm, the program will offer an overview of new federal nutrition labeling requirements, which take effect Jan. 1, 2020, for manufacturers …
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Kaiser to Present at PLI Life Sciences Program
September 17, 2019 | Rivkin Rounds Staff | Cybersecurity | Electronic Health Records | FDA | False Claims Act | Fraud and Abuse | Legislation and Public Policy | Litigation | Medical Devices and Wearables | Medicare and Medicaid | Pharmaceuticals | Private Insurers
On October 10, Rivkin Radler’s Jeff Kaiser will be a panelist at the Practising Law Institute (PLI) program, “Life Sciences 2019: Navigating Legal Challenges in the Drug and Device Industries.” Jeff will speak on “Enforcement Trends Impacting the Drug and Device Industries,” including developments under the False Claims Act, federal Anti-Kickback Statute, off-label promotion, and …
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Marijuana Legalization Bills Introduced in Congress
July 26, 2019 | Cassandra Rivais DiNova | Mark J. Wagner Jr. | Cannabis | FDA | Legislation and Public Policy
On July 23, companion legislation was introduced in the House and Senate by Senator Kamala Harris of California and New York Congressman Jerrold Nadler to legalize and tax marijuana at the federal level. The tax revenue from this legislation would support job training, substance abuse treatment, literacy programs, and other services for communities that have been …
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CVS Announces Home Dialysis Machine Trials
July 22, 2019 | Eric D. Fader | FDA | Home Health | Medical Devices and Wearables | Pharmaceuticals | Private Insurers
On July 17, CVS Health Corp. announced the beginning of human trials of a new home dialysis machine called the HemoCare Hemodialysis System. The company’s CVS Kidney Care unit hopes to shift some of the $35 billion market for end-stage kidney care from outpatient dialysis clinics to patients’ homes. The HemoCare device was designed by …
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FDA Warns on CBD Dietary Supplements
July 17, 2019 | Marc S. Ullman | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
In a July 9 Warning Letter to Ceba-Tek, Inc. focused mainly on issues relating to failure to comply with regulations on Good Manufacturing Practices for Dietary Supplements, the U.S. Food and Drug Administration (FDA) again commented on the issues confronting companies producing and marketing CBD as an ingestible: “It is a prohibited act to introduce …
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FDA in Fact-Finding Mode on CBD
June 20, 2019 | Eric D. Fader | Cannabis | FDA | Legislation and Public Policy | Pharmaceuticals
The U.S. Food and Drug Administration (FDA) released a Consumer Update regarding cannabidiol (CBD) on June 14. Observing that CBD “seems to be available almost everywhere,” the FDA noted that the science, safety, and quality of CBD-containing products are unproven and said that it is working to learn more about the safety of CBD. Unapproved …
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FDA Plans New Review Framework for AI-Based Medical Devices
April 24, 2019 | Eric D. Fader | FDA | Legislation and Public Policy | Medical Devices and Wearables
An April 2 Statement from Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration (FDA), announced that the FDA is considering creating a new review framework to promote development of medical devices that use artificial intelligence (AI) algorithms. The FDA also released a Discussion Paper and Request for Feedback on the proposed regulatory …
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Stem-Cell Clinics Under Fire
April 11, 2019 | Cassandra Rivais DiNova | FDA | Fraud and Abuse | Litigation
On April 3, the U.S. Food and Drug Administration (FDA) sent warning letters to about 20 stem-cell clinics notifying them that their activities appear to require FDA approval. The letters, similar in form to this one, cited guidance materials that clinics can use as resources in becoming compliant with FDA requirements. Stem-cell therapy involves removing …
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