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Long Time Passing: Where Have All the De Novo Decision Summaries Gone?
…DEN220044 02/03/2023 560 OHT7: Office of In Vitro Diagnostics PMD-200 DEN210022 02/17/2023 546 OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental Devices Pill Sense System DEN220065 02/24/2023 539 OHT3:…
Fourth Circuit Finds Maryland Price Gouging Law Unconstitutional
…the manufacturer or wholesaler. Therefore, a violative price gouging transaction may occur outside of Maryland even if the transaction “did not result in a single pill being shipped into Maryland.”…
Preemption Cases Involving FDA-Regulated Products are Increasing – Third Circuit Rules that FDA Approval Preempts State False Labeling Claims & Supreme Court Petitioned to Review REZULIN Case
…benefits to eligible Commonwealth of Pennsylvania employees, retirees, and their dependents, sued AstraZeneca alleging, among other things, that the company unlawfully advertised NEXIUM (esomeprazole magnesium) (i.e., the “Purple Pill”) in…
A Short-Term Gain for a Long-Term Loss? The Build Back Better Act’s Medicare Drug Price Negotiation Program Ignores Hatch-Waxman/BPCIA Realities . . . and that May Mean Big Bad Business for Generic Drug/Biosimilar Manufacturers
…product enough to obtain market share sufficient to offset their [development] costs.” That’s a difficult pill to swallow. It means less – or no – generic/biosimilar competition. After all, given…
Please Pass the Brownies – Uh – “Edible Retail Marijuana Products”
…Product” to mean “any Retail Marijuana Product which is intended to be consumed orally, including but not limited to, any type of food, drink, or pill” (emphasis added). The rules…
Federal Court Orders FDA to Approve OTC Emergency Contraception Without Restrictions, Describes Intervention by Secretary Sebelius as “Unprecedented” and “Politically Motivated”
…scathing opinion that reproached Secretary Sebelius for acting in bad faith and for allowing political considerations to trump the expertise of FDA’s scientists, Judge Korman stressed the importance of evidence-…
Would You Balk at Disclosing Confidential Information to Your Competitors?
…license for use of an aspect of the [ETASU] for the applicable listed drug and that it was unable to obtain a license. ETASU REMS have been a difficult pill…
FDA Seeks Comment on Tobacco Outdoor Advertising Restrictions; Eyes Posting of Graphic Anti-Tobacco Messages
…restrictions such as requiring stores to post graphic anti-tobacco messages. The notice regarding outdoor advertising restrictions likely will intensify debate about the constitutionality under the First Amendment of FDA’s proposed…
Pharmaceutical Patent Laws: A Prescription for Success in Challenging Times
…law go from here? The conference will be held at the Ritz-Carlton, Pentagon City, 1250 South Hayes Street, Arlington, VA, on November 12, 2008. A copy of the conference brochure…
President Biden Gives the Green Light for Significant Marijuana Reform
…Missouri, North Dakota, and South Dakota. We also note there are states where marijuana remains the equivalent of a schedule I controlled substance. Separate and apart from the loosening of…
Upcoming Conference on Digital Health Regulatory Issues
…& McNamara’s Jeffrey K. Shapiro is the Chair. The conference will be held in South San Francisco on June 6, 2019. The keynote address will be delivered by Bakul Patel,…
32 State AGs Urge U.S. Supreme Court to Take on Patent Settlement Agreements
…Maryland, Massachusetts, Minnesota, Mississippi, Missouri, Montana, Nebraska, Nevada, New Hampshire, New Mexico, North Carolina, Oklahoma, Ohio, Oregon, South Carolina, Tennessee, Texas, Utah, Vermont, Washington, West Virginia, and Wyoming. UPDATE: A…
HHS Issues Final Conflict of Interest Rules for PHS-Funded Research That Increases Burden to Institutions and Investigators
…changes to regulations issued in 1995 on the Responsibility of Applicants for Promoting Objectivity in Research for which Public Health Service Funding is South and Responsible Prospective Contractors (42 C.F.R….
KV Takes a Hit With the Dismissal of Its Case Against FDA Over Compounded 17P
…of Columbia dealt a blow to K-V Pharmaceutical Company’s (“KV’s”) efforts to “restore” orphan drug exclusivity for the pre-term birth drug MAKENA (hydroxyprogesterone caproate) Injection, 250 mg/mL, by granting FDA’s…
ACI’s 42nd FDA Boot Camp – New York City Edition
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South,…