National Institute on Drug Abuse: Nora's Blog

JANUARY 3, 2025

A new roadmap for cannabis and cannabis policy research mfleming Fri, 01/03/2025 - 11:38 Nora's Blog January 14, 2025 Image Getty Images/ Fiordaliso The greatly increased availability of cannabis over the last two decades has outpaced our understanding of the public-health impacts of the drug.

Research 78

Research Production Licensing Licensing 78

Agency IQ

FEBRUARY 15, 2024

MHRA selects eight technologies to help it test its new innovative devices pathway The British regulator and its partners just released the list of products and companies chosen to participate in the pilot of its Innovative Device Access Pathway (IDAP). device regulations and the pilot for innovative products. and abroad.

Regulations 40

Regulations Science Production Vaccine 40

The Pharma Data

DECEMBER 12, 2020

Double-digit revenue growth through 2025; acquisition strengthens AstraZeneca’s broad-based revenue and the company will further globalise Alexion’s portfolio . The combined company is expected to deliver double-digit average annual revenue growth through 2025. Dedicated rare disease unit to be headquartered in Boston.

Regulations 75

Regulations International Disease Small Molecule 75

Agency IQ

MARCH 7, 2024

flu vaccines Yesterday, FDA’s Vaccines and Related Biological Products Advisory Committee (VRBPAC) weighed in on strains for seasonal influenza vaccines for the Northern hemisphere 2024-2025 season. Vaccines advisory panel endorses move to trivalent formulation for U.S. Advisory committee members were less convinced.

Vaccine 40

Vaccine FDA Virus Licensing 40

Agency IQ

SEPTEMBER 1, 2023

s MHRA unveiled details of its new International Recognition Procedure, which will allow the MHRA to rely on marketing authorizations by reference regulators from several countries for a wide range of products, including generics and those that received expedited review. from the E.U. pharmaceutical law ceased to apply to the U.K.

International 40

International Regulations Production Marketing 40

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

JULY 22, 2024

AgencyIQ provides a status update for regulated industry. Intro: The FDA’s rule on diagnostics and what it means for developers A quick intro about how FDA regulates In vitro diagnostics (IVDs) and Laboratory Developed Tests (LDTs): In the U.S., diagnostic products are regulated as medical devices. The rule amends 21 CFR 809.3(a)

FDA 40

FDA Laboratories Regulations Clinical Trials 40

Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Production 40

Agency IQ

AUGUST 16, 2024

By Amanda Conti | Aug 13, 2024 10:00 PM CDT Regulatory context: Psychedelic regulation and drug development A growing body of evidence suggests that psychedelics may provide clinical benefit for certain purposes, especially mental health conditions. This study is planned to start in late 2024 and conclude in late 2025.

FDA 40

FDA Trials Therapies Regulations 40

Agency IQ

JULY 22, 2024

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). The regulators were off to a slow start, with just three total approvals in the first two months of 2024. Most NMEs approved so far this year relied on one pivotal trial.

Clinical Trials 52

Clinical Trials Trials Science FDA 52

The Pharma Data

FEBRUARY 4, 2021

As part of the event, AbbVie raised its 2025 risk-adjusted combined sales guidance for Skyrizi and Rinvoq to greater than $15 billion , above previous guidance of greater than $10 billion. The company reiterated its expectation for greater than $15 billion of risk-adjusted combined Rinvoq and Skyrizi global sales in 2025.

Production 52

Production Clinical Trials International Small Molecule 52

Agency IQ

JUNE 21, 2024

Sponsors would , if selected for the pilot, “receive more frequent advice related to such specific issues through additional interactions to facilitate novel drug and biological product program development and generate high quality and reliable data intended to support a Biologics License Application (BLA) or New Drug Application (NDA).”

Disease 40

Disease Science FDA Production 40

The Pharma Data

MAY 4, 2021

Even excluding the growth provided from BNT162b2, our revenues grew 8% operationally, which aligns with our stated goal of delivering at least a 6% compound annual growth rate through 2025. 7) BNT162b2 has not been approved or licensed by the U.S. CAPITAL ALLOCATION. If approved, TicoVac would be the first vaccine in the U.S.

Vaccine 40

Vaccine Production FDA Clinical Trials 40

Agency IQ

AUGUST 9, 2024

Most research to date has provided doses in a highly controlled, positive environment, often with a licensed mental health practitioner present to help guide the participant through the experience. The April 2024 multi-day workshop showcased presentations and panels from various regulators, trade groups, academics and patient advocates.

Clinical Trials 40

Clinical Trials Regulations Trials FDA 40

Agency IQ

FEBRUARY 2, 2024

What We Expect the FDA to do in February and March 2024 (Updated) In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Clinical Trials Regulations 40

Agency IQ

FEBRUARY 15, 2024

CDER, CBER Draft 12/29/2025 FDA must issue final guidance no later than 18 months after the close of the public comment period for draft guidance. Priority B List. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

FDA 40

FDA Science Biosimilars Clinical Trials 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. This information would be used in considering the regulation of asbestos.

Regulations 40

Regulations Compliance Production Science 40

Drug Target Review

MARCH 13, 2025

The journey from distrust to collaboration among industry, academia and regulators will expedite integration, minimise clinical failures and enhance economic sustainability. Surveys (eg, 2024 State of Tech in Biopharma Report ) predict a doubling of R&D data year-over-year in 2025, highlighting the continued growth of available data.

Drug Development 59

Drug Development Science Clinical Trials FDA 59

FDA Law Blog: Biosimilars

FEBRUARY 18, 2025

Lewis, , Principal Regulatory Device and Biologics Expert The FDA is currently funded through March 1st, 2025. The question that is always on the mind of folks in FDA-regulated industries is, what does that mean for my application/inspection/meeting? By Richard A.

Government 76

Government Compliance FDA Licensing 76

Codon

JANUARY 8, 2025

As we enter 2025, we’ve noticed that our list of ideas has ballooned into the hundreds. In ideal circumstances, our circadian rhythms work well and regulate our hormonal cycles and mood. What other discoveries might move us closer to being able to regulate our sleep cycles at the molecular level without damaging our health?

Science 62

Science Vaccine Engineering Disease 62

FDA Law Blog: Biosimilars

NOVEMBER 21, 2024

temporary exceptions from some of the requirements of the Ryan Haight Act of 2008) are extended for an additional year, until December 31, 2025. Thus, while continuing to review industry feedback, DEA is still working on promulgating a more workable final set of telemedicine regulations. The federal telemedicine flexibilities (i.e.,

FDA Approval 52

FDA Approval Regulations Pharmacy Licensing 52

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. Of those 53, seven are new to the Agenda, having never before been included in prior agendas.

Regulations 40

Regulations FDA Science Production 40