The FDA Law Blog

JANUARY 11, 2024

HPM) Directors, Karla Palmer and Dara Levy , will present at the Puerto Rico Pharmaceutical Summit 2024, February 6, 2024, at the La Concha Renaissance San Juan Resort in San Juan, Puerto Rico. Two Hyman, Phelps & McNamara, P.C.

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The FDA Law Blog

JANUARY 24, 2024

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, New York. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks! Join our co-chairs Kurt R.

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The FDA Law Blog

JUNE 27, 2024

District Court for the District of Texas on Zarzamora Healthcare LLC for repeatedly dispensing opioids and other controlled substances “by filling prescriptions while ignoring red flags.” 50,372 , 50,377 (June 13, 2024). Last December we blogged on the $275,000 civil penalty imposed by the U.S. 72,694, 72,703 (Dec. 21 U.S.C. §

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The FDA Law Blog

MAY 10, 2023

Palmer — We blogged earlier this week here that DEA is reconsidering its proposed rules for telemedicine prescribing of controlled substances and buprenorphine. effective May 12, 2023 through November 11, 2024, Telemedicine relationships that are included in this period must be “in effect” as of November 11, 2023. By Karla L.

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The Checkup by Singlecare

MARCH 4, 2025

Adults and pediatric patients 12 years and older Adults 17 years and older Qsymia vs. phentermine: Conditions treated Qsymia is approved by the Food and Drug Administration (FDA) for weight loss and long-term weight management in adults and pediatric patients 12 years and older with obesity. of body weight compared to 13.7%

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The Checkup by Singlecare

MARCH 1, 2024

But determining whether someone needs it is challenging, and because it’s a controlled substance, getting a prescription can be, too. Food and Drug Administration (FDA) classifies it as a category C drug , meaning animal studies have found adverse effects on the fetus. Do you need an Adderall prescription?

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The FDA Law Blog

APRIL 21, 2024

Post-AIA, and a later change to the law to account for controlled substance FDA application approvals, the PTE statute at 35 U.S.C. § Rather, “permission for commercial marketing” was only effective upon FDA’s issuance of its corrected October 5, 2022 letter. which brings us to the topic of this post. Patent Nos.

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The Checkup by Singlecare

AUGUST 15, 2024

Food and Drug Administration (FDA) for chronic weight management as an adjunct to a reduced-calorie diet and increased physical activity in those who meet the defined body mass index (BMI) criteria. This would be off-label use of the medications because the FDA approves neither for weight loss. Contrave is approved by the U.S.

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The FDA Law Blog

DECEMBER 12, 2024

The NPRM seeks to reschedule marijuana from schedule I of the federal Controlled Substances Act (CSA) to schedule III. 4, 2024), at 1. The DEA Administrator issued a General Notice of Hearing fixing December 2nd as the commencement date for the hearing. Prehearing Ruling (Dec.

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The FDA Law Blog

FEBRUARY 27, 2024

156, a patent may be extended only once (even if it would be eligible for extension on more than one occasion because it applies to several FDA-approved products), and only one patent may be extended for each regulatory review period. This means that there multiple same-day FDA NDA approvals for the same drug. FDA-2020-E-1840 (Mar.

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The FDA Law Blog

JULY 1, 2024

Karst — The Drug Enforcement Administration (“DEA”) has received more than 2 7 ,000 public comments in response to its May 21, 2024 , Notice of Proposed Rulemaking (“ NPRM ”) to reschedule marijuana from schedule I to schedule III. Letter to DEA Administrator Anne Milgram, from Peter Bensinger, et al., ( June 19, 2024 ).

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The FDA Law Blog

APRIL 17, 2024

DEA, with its law enforcement partners, will host thousands of local drop-off locations nationwide for clearing out and proper disposal of unwanted expired and unneeded medication from medicine cabinets between 10:00 am to 2:00 pm local time on Saturday, April 27, 2024. Events over the years have led to the removal of more than 17.9

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The Checkup by Singlecare

APRIL 2, 2024

Food and Drug Administration (FDA) to treat obesity in the short term and is meant to be combined with exercise, calorie reduction, and behavioral modifications. RELATED: Overweight and obesity statistics 2024 Where can I get phentermine? The FDA offers tips on how to choose a legitimate online pharmacy.

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The Checkup by Singlecare

MAY 5, 2024

Food and Drug Administration (FDA) for the treatment of ADHD symptoms. Either can control the symptoms of ADHD for as long as the disorder persists. In addition to uses for ADHD, Vyvanse is FDA-approved for binge eating disorder in adults. It can be frustrating not to be able to get your prescribed medicine.

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The FDA Law Blog

MAY 21, 2024

Houck — Last August Health and Human Services (“HHS”) recommended rescheduling marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The NPRM was signed by the Attorney General but published by DEA in the Federal Register on May 21, 2024. 44,597 (May 21, 2024). By Larry K.

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The FDA Law Blog

APRIL 8, 2024

Department of Health and Human Services (HHS) recently published a White Paper on Policy Considerations to Prevent Drug Shortages and Mitigate Supply Chain Vulnerabilities in the United States —with input from several HHS stakeholders, including FDA, CMS, and the Administration for Strategic Preparedness and Response.

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The FDA Law Blog

DECEMBER 21, 2023

Director Larry Houck will present a webinar on HHS’ cannabis rescheduling recommendation hosted by the National Association of State Controlled Substance Authorities (“NASCSA”) scheduled for Tuesday, January 9, 2024 at 3:00 pm (Eastern). Hyman, Phelps & McNamara, P.C.,

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The FDA Law Blog

NOVEMBER 26, 2024

Houck — Last May the Department of Justice (“DOJ”) and the Drug Enforcement Administration (“DEA”) issued a Notice of Proposed Rulemaking (“NPRM”) to transfer marijuana from schedule I of the Controlled Substances Act (“CSA”) to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed.

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The FDA Law Blog

MARCH 24, 2025

Department of Health and Human Services (HHS), based on the federal Controlled Substances Acts (CSAs) Eight Factor Analysis, recommended that the Drug Enforcement Administration (DEA) reschedule marijuana from schedule I to schedule III. Schedules of Controlled Substances: Rescheduling of Marijuana, 89 Fed. By Larry K.

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The Thyroid Pharmacist

NOVEMBER 15, 2024

17] Ozempic is a once-weekly injection that was approved by the FDA in 2017 for use in adults with type 2 diabetes. I also prefer semaglutide drugs over other weight loss drugs out there (for example, phentermine, a controlled substance that can be habit forming, or orlistat, a drug that results in fat malabsorption and “disaster pants”).

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The FDA Law Blog

NOVEMBER 21, 2024

Palmer — In a Temporary Rule announced on November 19, 2024, DEA with input from HHS again extended current telemedicine flexibilities, which were first initiated on January 31, 2020 at the inception of the COVID-19 pandemic. By Karla L. The federal telemedicine flexibilities (i.e., The federal telemedicine flexibilities (i.e.,

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The FDA Law Blog

MARCH 6, 2025

109 (2024), the Supreme Court upheld a decision by the U.S. (For an in-depth review of the history of ALJs and the removal protections enacted by the APA, see Brief of Amicus Curiae Federal Administrative Law Judges Conference 8-20, SEC v. Jarkesy , No. 22-859 (Sept. The constitutionality of ALJs has been a hot legal topic of late.

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The FDA Law Blog

APRIL 22, 2024

Houck — Administrator Anne Milgram has been on the receiving end of high-level support for and against rescheduling marijuana since the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended the Drug Enforcement Administration (“DEA”) reschedule from schedule I to schedule III last August. By Larry K.

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The FDA Law Blog

MAY 5, 2024

Houck — The Associated Press reported on Tuesday following confirmation by five anonymous individuals with knowledge that the Drug Enforcement Administration (“DEA”) is moving to reschedule marijuana from schedule I to the less stringently controlled schedule III. Whether the drug is an immediate precursor of a substance already controlled.

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The FDA Law Blog

FEBRUARY 11, 2024

FDA has not approved marijuana for medical use because no double-blind, published studies show safety and efficacy for raw marijuana. Letter 3: Top Ten Reasons for Descheduling Cannabis Altogether From: Democratic Senators Date: January 29, 2024 Twelve Democratic senators signed Letter 3. January 29, 2024).

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The FDA Law Blog

APRIL 29, 2024

Houck — On April 23, 2024 we blogged about Republican Senators Mitt Romney, Pete Ricketts and James Risch advising Drug Enforcement Administration (“DEA”) Administrator Anne Milgram to consider U.S. April 24, 2024. from Michael Miller, April 16, 2024. By Larry K. Letters to Elizabeth Warren, et al.,

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