FDA Law Blog: Biosimilars

JANUARY 11, 2024

The first commercial marketing of each, according to the biosimilar patent settlement agreement, was July 1, 2023, which would render the FIE expiration date July 1, 2024. But because the statute sets FIE expiration at the earlier of the relevant conditions, the April 15, 2023 and September 28, 2023 dates were the FIE expiration dates.

Biosimilars 59

Biosimilars FDA Production Marketing 59

Agency IQ

JUNE 16, 2023

The Agenda also includes several long-term actions expected to take place in 2024 and 2025 – included as part of FDA’s long-term regulatory agenda. The anticipated date of publication is June 2023, meaning we should see this regulation imminently. Some of the affected former NDAs were approved using drug master files (DMFs).

Regulations 40

Regulations FDA Science Production 40

Agency IQ

JANUARY 19, 2024

BY KIRSTEN MESSMER, PHD, RAC | JAN 17, 2024 9:16 PM CST Quick background: EMA annual new medicines reports At the beginning of each calendar year, the EMA publishes a New Medicines Highlights report, providing a high-level overview of new medicines reviewed by the EMA’s Committee for Medicinal Products of Human Use (CHMP). Based on the E.U.

Biosimilars 40

Biosimilars FDA Production Treatment 40

Agency IQ

JANUARY 26, 2024

BY CHELSEY MCINTYRE, PHARMD | JAN 24, 2024 4:09 PM CST Back to the beginning: What does an expiration date mean to the FDA? What happens when a drug is not stored in its original container or within a licensed facility? Enter the beyond-use date. When such a situation is identified, it is noted in the product labeling.

Science 40

Science FDA Production Packaging 40

Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

FDA 40

FDA Drugs Production Licensing 40

Agency IQ

OCTOBER 27, 2023

and Annex 1 Conference Joel Welch December 18 RAPS RAPS Webcast: FDA Forecast: What’s Next for the FDA in 2024 AgencyIQ Speakers December 21 HL7 REMS Public Call PDUFA Dates expected in November and December PDUFA dates represent the expected date of a regulatory decision by the FDA on a New Drug Application or Biologics License Application.

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 4, 2023

These features should not be included on outer packaging or immediate packaging, if there is no outer packaging. Last week, the MHRA provided a roadmap for upcoming labeling requirements, based on license type The Windsor Framework allows the MHRA to approve medicines for U.K. wide license: The requirements of the E.U.

Packaging 40

Packaging Licensing Licensing Regulations 40

Agency IQ

DECEMBER 1, 2023

and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Morgan Chase 42 nd Annual J.P. The following PDUFA dates were obtained from publicly available sources.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

Highlights of the EPA’s Unified Agenda for Spring 2023 The Office of Management and Budget has released the Unified Agenda for Spring 2023, which outlines the regulations that agencies expect to release in 2023 and 2024. EPA’s FIP was due January 7, 2021. Comite Progreso de Lamont v. Cal, 21-cv-08733).

Regulations 40

Regulations Compliance Production Science 40

FDA Law Blog: Biosimilars

FEBRUARY 2, 2025

By Sara M Keup In reviewing some new 2025 pharmacy rules/laws a couple interesting changes caught this bloggers attention: As of December 30, 2024, Missouri has rolled out new rules related to prescription drug delivery requirements. Massachusetts will begin enforcement against non-licensed pharmacy dispensing beginning on May 1, 2025.

Licensing 59

Licensing Licensing Pharmacy Packaging 59

Drug Target Review

FEBRUARY 19, 2025

These challenges were the focus of a panel discussion at the 2024 Advanced Therapies Europe (ATE24) conference, led by two prominent experts: Dr Boris Greber, Head of R&D, iPSC at Catalent Cell & Gene Therapy in Europe, and Dr Frederic Cedrone, Vice President of Corporate Innovation at Catalent.

Therapies 59

Therapies Molecular Biology Regulations Packaging 59

Agency IQ

JULY 28, 2023

September 2023 Final Rule Stage Biologics License Applications and Master Files The Biologics Price Competition and Innovation Act of 2009 (BPCI Act) deemed any biological product approved in a new drug application (NDA) to be a biologics license application (BLA) on March 23, 2020.

FDA 40

FDA Science Biosimilars Regulations 40

Agency IQ

JANUARY 12, 2024

BY ALEXANDER GAFFNEY, MS, RAC | JAN 5, 2024 4:59 PM CST Regulatory Background and Context Under 21 USC 384, also known as Section 804 of the Federal Food, Drug and Cosmetic Act (FD&C Act), HHS has the authority to issue regulations allowing wholesale drug importation.

FDA Approval 40

FDA Approval FDA Science Drugs 40

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond. The latest update, announced this week, is known as the Spring 2024 Unified Agenda.

Regulations 40

Regulations FDA Science Production 40

Codon

FEBRUARY 23, 2025

In 2024, the pharmaceutical company Gilead announced that a single injection of lenacapavir protected 96 to 100 percent of recipients from HIV for up to six months. By 1987, the FDA licensed zidovudine after trials showed it increased survival rates. If a permanent freeze goes into effect, researchers estimate there could be 8.7

Clinical Trials 65

Clinical Trials Virus Vaccine DNA 65

Drug & Device Law

FEBRUARY 29, 2024

3d __, 2024 U.S. LEXIS 22420, 2024 WL 487769 (C.D. 2:23-cv-2853 WBS DB, 2024 U.S. 21, 2024)). The PREP Act has captured our attention before, but recently, in Baghikian v. Providence Health & Services , No. CV 23-9082-JFW(JPRX), __ F.Supp.3d 247d-6d(a)(2)(B). Baghikian already has been followed in Fust v.

Government 59

Government Production FDA Clinical Trials 59

Drug & Device Law

FEBRUARY 19, 2024

That regulation provides that a prescription-only drug – one that can only be obtained through “a practitioner licensed by law to administer or prescribe such drugs” bearing “[t]he statement ‘Rx only’” – is “exempt” from requirements to provide adequate directions for use to patients. 2024 WL 477523, at *3 (Mag. 201.100(a-b).

Licensing 52

Licensing Licensing Regulations FDA 52

Drug & Device Law

DECEMBER 29, 2023

Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. 122 (2023), are beginning to percolate through the Pennsylvania courts, and may see appellate action as soon as late 2024. See you in 2024.

Testimonials 105

Testimonials Drugs FDA Vaccine 105