FDA Law Blog: Biosimilars

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. § 112-029 ), titled “Calculation of 60-Day Period for Application of Patent Term Extension” and referred to by some as “The Dog Ate My Homework Act” or the “Medco Fix.” Patent Nos.

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Labelling Controlled Substances 59

FDA Law Blog: Biosimilars

APRIL 8, 2024

The White Paper notes that of the 123 drugs in shortage in January 2024, a quarter were first reported in shortage prior to 2020, with the oldest dating back to 2012, and shortages were experienced across therapeutic areas; analgesics/anesthetics (17%), anti-infective (12%), and cardiovascular (13%) products comprised 42% of shortages.

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FDA Law Blog: Biosimilars

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.

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Controlled Substances 59

Integra X Files

FEBRUARY 20, 2023

Beginning in 2024, the administration fee for COVID-19 immunizations will be in line with other Medicare Part B vaccines. The ability to prescribe controlled substances without an in-person consultation will end with the expiration of the PHE.

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LifeProNow

MARCH 10, 2023

billion as part of the president’s fiscal year (FY) 2024 budget. The FY 2024 request, which covers the period from Oct. 30, 2024, includes new efforts for high priority program areas. March 09, 2023: “The U.S. Food and Drug Administration announced it is requesting $7.2 1, 2023, through Sept.

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FDA Law Blog: Biosimilars

JANUARY 18, 2024

Houck — In August 2023 the Food and Drug Administration (“FDA”) and Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule marijuana from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. HHS forwards FDA’s analysis and recommendation to DEA.

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FDA Law Blog: Biosimilars

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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Controlled Substances 52

FDA Law Blog: Biosimilars

FEBRUARY 27, 2024

On February 8, 2024—the same day the PTO requested information with respect to the multiple PTE applications for idelalisib—the FDA sent a letter to the PTO in response to the PTE applications for for U.S. Karst — It’s been a while since we last blogged on Patent Term Extension (“PTE”) issues of interest. Patent Nos. 7,214,695 and 7,214,696.

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FDA Law Blog: Biosimilars

APRIL 22, 2024

Milgram’s predecessors, and Directors of National Drug Policy urging not to reschedule; the January 2004 letter Democratic state attorneys general pushing for rescheduling to schedule III; and the January 2024 letter from Democratic senators requesting descheduling altogether. The senators write that the U.S.

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Controlled Substances 59

FDA Law Blog: Biosimilars

FEBRUARY 11, 2024

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). Letter to DEA Administrator Anne Milgram, from Phil Weiser, et al., (Jan.

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FDA Law Blog: Biosimilars

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. treaty obligations in rescheduling. 21 U.S.C. § 812(b)(1).

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FDA Law Blog: Biosimilars

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. Vice president criticizes federal cannabis restrictions during White House weed event , March 15, 2024.)

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Controlled Substances 59