Sygnature Discovery

NOVEMBER 29, 2023

It was conceived, invented and developed by Professor Stephen Neidle and his team in the School of Pharmacy at University College London with the involvement of Sygnature Discovery scientists. They anticipate providing an update on safety and preliminary efficacy of the Phase 1a study in the first half of 2024.

Clinical Trials 40

Clinical Trials Treatment Trials Small Molecule 40

Agency IQ

FEBRUARY 15, 2024

166 guidance documents the FDA is actively working on in 2024 (and beyond) The FDA is set to be very, very busy in 2024. We’ve identified a total of 166 guidance documents that are under active development, and have the key details for you below.

FDA 40

FDA Science Biosimilars Production 40

Agency IQ

MARCH 25, 2024

BY CHELSEY MCINTYRE, PHARMD | MAR 20, 2024 10:32 PM CDT Background: Drug compounding in the U.S. Products compounded by 503A pharmacies are specifically exempt from needing to adhere to Current Good Manufacturing Practice (cGMP) requirements, labeling regulations and new drug approval requirements. What is drug compounding?

FDA 40

FDA Pharmacy Production Drugs 40

FDA Law Blog: Biosimilars

DECEMBER 3, 2023

As part of this change, the Coverage Gap Discount Program (CGDP), a program that has existed since 2011, will sunset on December 31, 2024, and be replaced by the Medicare Part D Manufacturer Discount Program (the “Discount Program”). Manufacturers must sign the agreement by March 1, 2024, to participate in the 2025 plan year.

Compliance 105

Compliance Pharmacy Drugs Licensing 105

Agency IQ

FEBRUARY 12, 2024

A closer look at CDER’s new 2024 guidance agenda The FDA’s Center for Drug Evaluation and Research, its drug review division, this week quietly updated its 2024 Guidance Agenda, a list of all draft guidance documents the agency is working on this calendar year. Read Agency IQ’s breakdown of the 2024 CDRH guidance agenda here].

Biosimilars 40

Biosimilars Science Clinical Pharmacology FDA 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? According to a National Survey of Pharmacy Law conducted in 2015, that number had already increased to 27 states.

Science 40

Science FDA Packaging Production 40

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 rule, will also, if finalized, address communication with State boards of pharmacy. The anticipated date of publication is June 2023, meaning we should see this regulation imminently.

Regulations 40

Regulations FDA Science Production 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

Codon

FEBRUARY 13, 2024

Phage-based products have been licensed for use as antibacterial agents in the sanitation , food production , and animal health industries. Crucially, it could also make them easier to license as therapeutic agents. Phage therapies are sold at a pharmacy in Georgia. Asimov Press (2024). Cite this essay: Tom Ireland.

Therapies 118

Therapies Virus DNA Clinical Trials 118

Agency IQ

SEPTEMBER 29, 2023

AgencyIQ November 27 DSCSA Technically goes into full effect While the FDA has technically extended enforcement of certain provisions under the Drug Supply Chain Security Act until November 2024, certain provisions of the law are still due to come into effect in late November.

FDA 40

FDA Science Regulations Production 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

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. That meant both the pharmacist and the pharmacy where the vaccine was administered “covered persons” under the act. See you in 2024. Preemption did the rest.

Testimonials 105

Testimonials FDA Drugs Vaccine 105