Lanton Law was quoted in Pharmacy Times article titled “Mifepristone Has its Day in Court.” The article discusses the drug amid its backdrop in the U.S. Supreme Court.
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Lanton Law was quoted in the Pharmacy Times article titled “FDA Approves First Nonprescription Daily Birth Control Pill.”
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Although the FDA has now allowed retail pharmacies to dispense mifepristone, a drug used for medicated abortions, questions still remain about the requirements for pharmacies and the availability of the drug. Lanton Law talks to Pharmacy Times in an interview about a post Dobbs world with mifepristone.
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In an interview with Pharmacy Times, Ron Lanton III, Esq, partner at Lanton Law, discussed the recent Supreme Court ruling on Dobbs v. Jackson Women’s Health and what this could mean for pharmacists. In the interview, Lanton said the decision leaves many things ambiguous, which will most likely result in litigation around the country in the coming weeks and months.
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In an interview by Aislinn Antrim of Pharmacy Times called “Calling Them ‘Vanity Drugs,’ Some Insurers Refuse to Cover New Anti-Obesity Drugs,” Ron Lanton III, Esq., Partner at Lanton Law, discussed why insurers are refusing to cover new, highly effective anti-obesity drugs and how some prescribers are getting around the issue. Lanton said that this is a common issue across many different disease spaces and drug types, but some policy changes may be able to help.
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The FDA has just released draft guidance in the Biden Administration’s effort to encourage the industry to enhance clinical trial diversity.
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The FDA has just released a new cybersecurity draft titled “Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.”
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According to the Food and Drug Administration proposed rule, the (FDA) is “proposing national standards for the licensing of prescription drug wholesale distributors (“wholesale distributors” or “wholesale drug distributors”) and third-party logistics providers (“3PLs”), as directed under the Drug Supply Chain Security Act (DSCSA) (Title II of the Drug Quality and Security Act). Pursuant to the Federal Food, Drug, and Cosmetic Act (FD&C Act), as amended by the DSCSA, the proposed rule would establish standards for all State and Federal licenses issued.”
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The Access to Prescription Digital Therapeutics Act of 2022 has been introduced by Reps. Mike Thompson (D-CA) and David McKinley (R-WV) and Sens. Jeanne Shaheen (D-NH) and Shelly Moore Capito (R-WV).
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Congress has introduced the CBD Product Safety and Standardization Act “that will establish federal standards for CBD food and beverage products to protect consumers and provide marketplace stability for farmers, producers, and retailers.”
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According to the FDA’s press release, “The U.S. Food and Drug Administration approved the first interchangeable biosimilar product to treat certain inflammatory diseases.”
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Senators Dianne Feinstein (D-Calif.), Chuck Grassley (R-Iowa) and Brian Schatz (D-Hawaii) have introduced the Cannabidiol and Marijuana Research Expansion Act.
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Earlier this month, the FDA released its first Artificial Intelligence/Machine Learning (AI/ML)-Based Software as a Medical Device (SaMD) Action Plan.
As part of its breakthrough, the FDA pointed out some interesting aspects of its new policy area.
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With all the attention on the 2020 elections, what may have been lost in the fray was the announcement that the FDA created the Digital Health Center of Excellence, within the Center for Devices and Radiological Health (CDRH). According to the FDA’s release, the new Center is dedicated “to the advancement of digital health technology, including mobile health devices, Software as a Medical Device (SaMD), wearables when used as a medical device, and technologies used to study medical products.”
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On September 21st the FDA closed its comment period related to cannabis. Back in July the Food and Drug Administration (FDA) announced the availability of a draft guidance for industry entitled “Cannabis and Cannabis-Derived Compounds: Quality Considerations for Clinical Research.”
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As of today, March 23, 2020, the life sciences industry completes “the transition.” New categories of biologics will now be licensed via the biologics approval pathway under the Biologics Price Competition and Innovation Act (BPCIA). This transition occurs 10 years after the 2009 enactment of the BPCIA.
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During the 2019 National Association of Specialty Pharmacy Annual Meeting and Expo, Ron Lanton III, Esq, reviewed the FDA Biosimilars Action Plan, its implications for the biosimilar marketplace, recent legislation set to influence the biosimilar pathway and drug accessibility, and the future of the biosimilar market.
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Lanton Law gave a December 2019 webinar with the American College of Apothecaries ACA on CBD. Since then we have seen two significant developments.
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A new US Food and Drug Administration (FDA) policy may help get novel biosimilar insulins to market more quickly, but it will be no guarantee that the products will be significantly less expensive than branded insulins, say analysts.
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