PPD

JULY 20, 2023

In clinical research, the role of drug packaging systems cannot be overlooked. Industry guidelines require biopharmaceutical and biotechnology companies to test their pharmaceutical packaging systems, as the systems often experience prolonged and intimate contact with drug products, drug substances and intermediates.

Packaging 52

Packaging Laboratories Pharmaceutical Companies Compliance 52

Alta Sciences

JANUARY 31, 2025

Guest Blog: Reflecting on the 2024 Society of Toxicology of Canada Symposium, by Ria Falvo, Director, Reporting pmjackson Fri, 01/31/2025 - 15:47 Ria Falvo, Director of Reporting, and Rina Massarelli, Associate Director of Safety Reporting, in Toronto, Ontario, for the 2024 STC Symposium.

Cell Biology 52

Cell Biology Pharmaceutical Companies Clinical Research Government 52

Conversations in Drug Development Trends

MAY 23, 2024

The Critical EU-CTR Transition Deadline The three-year transition period for clinical trials authorized under the CTD that are expected to continue beyond the critical deadline of 30 January 2025 are required to transition to the new EU-CTR via a transition application through the CTIS.

Trials 52

Trials Clinical Trials Therapies Treatment 52

Vial

APRIL 18, 2024

The urgency for novel therapeutic approaches makes ophthalmology a rapidly growing domain of clinical research. Market research indicates significant growth in the ophthalmic clinical trials market, driven by increased disease prevalence, demand for ocular treatments, and rising research funding.

Clinical Trials 52

Clinical Trials Trials Treatment Clinical Research 52

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

Alta Sciences

APRIL 4, 2025

Getting to the Heart of Science: How Clinical Research Saved My Life and Continues to Inspire Me pmjackson Fri, 04/04/2025 - 18:01 By Josiah Liang, Research Laboratory Technician, Clinical Diagnostic and Central Laboratory Services. How Clinical Research Saved My Life I was born in 2000.

Clinical Research 52

Clinical Research Science Research Research Laboratories 52

FDA Law Blog: Drug Discovery

JUNE 9, 2025

Since 1993, Congress has continued to direct the federal government, and in particular FDA, to take steps to close the gap in clinical research representation. For example: The Food and Drug Modernization Act of 1997 (FDAMA) directed FDA to develop guidance on the inclusion of women and minorities in research.

Clinical Research 59

Clinical Research Research Clinical Trials FDA 59

Alta Sciences

JULY 31, 2024

Food and Drug Administration (FDA) published a draft guidance to ensure greater diversity in clinical trials, which is expected to become a final guidance by June 2025. Image Thumbnail_diversity in clinical trials_VAbutton.jpg Synopsis Representation and inclusion of various minority groups is crucial for medical research.

Clinical Trials 52

Clinical Trials Trials Clinical Pharmacology Drug Development 52

FDA Law Blog: Drug Discovery

JULY 9, 2024

Another question is the impact on rare disease drug development, where broader populations are small and there may be limited knowledge about differential impacts of disease. This means, under Congress’s direction in FDORA, the FDA should be trying to finalize the Draft Guidance around June 2025.

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FDA Clinical Trials Disease Trials 59

Agency IQ

AUGUST 9, 2024

EMA’s psychedelic workshop leaves stakeholders with as many questions as answers Earlier this year, the EMA hosted a multi-stakeholder workshop to discuss regulatory issues surrounding drug development of psychedelic products. has published psychedelic-specific guidance and has several ongoing psychedelic clinical trials.

Clinical Trials 40

Clinical Trials Regulations Trials FDA 40

Agency IQ

OCTOBER 27, 2023

WUSF / AgencyIQ November 1 Initial deadline for NDSRIs Under a 2023 guidance document, the FDA has recommended that pharmaceutical companies assess Nitrosamine Drug-Related Substance Impurities for their products by November 1, 2023, with confirmatory testing due by August 1, 2025.

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FDA Science Regulations Production 40

Agency IQ

JUNE 28, 2024

See AgencyIQ’s analysis for more detailed history of FDA’s policy and guidance on diversity in research studies ]. In April 2022, the FDA issued a draft guidance document on diversity in clinical research programs. Read AgencyIQ’s extensive analysis of the draft guidance here.]

FDA 40

FDA Science Clinical Trials Production 40

Agency IQ

FEBRUARY 2, 2024

Start Date End Date Event Event Type Center 01/10/2024 01/10/2024 FDA Oncology Center of Excellence Presents: Conversations on Cancer: “Bringing Innovation to People Facing Cancer” Webcast Office of the Commissioner 01/26/2024 01/26/2024 Medical Device Sterilization Town Hall: FDA Activities and Challenges in Reducing Reliance on Ethylene Oxide (EtO) (..)

FDA 40

FDA Science Clinical Trials Regulations 40

BioPharma Drive: Drug Pricing

JUNE 9, 2025

Deep Dive Library Events Press Releases Topics Sign up Search Sign up Search Pharma Biotech FDA Clinical Trials Deals Drug Pricing Gene Therapy An article from Sponsored The golden era of GLP-1 drugs: How will it impact medicine and society? By Ned Pagliarulo • June 4, 2025 Keep up with the story.

Clinical Trials 143

Clinical Trials Drugs Therapies Clinical Supply 143

PPD

JANUARY 21, 2025

As 2025 kicks off, the biopharma and biotech industries find themselves at a pivotal juncture, navigating an era of rapid transformation marked by new technological advancements, evolving regulations and shifting industry priorities. However, amid this progress, the complexities of drug development have never been more apparent.

Clinical Trials 52

Clinical Trials Trials Clinical Research Drug Development 52

PPD

MAY 9, 2025

The PPD clinical research business of Thermo Fisher Scientific conducted its third annual Pulse Report a survey of 150 leaders from biotech and pharmaceutical organizations worldwide.

Clinical Trials 52

Clinical Trials Drug Development Clinical Research Clinical Development 52

PPD

MARCH 19, 2025

The drug development landscape continues to grow in complexity and cost. Drug developers should consider several approaches when implementing an FSP partnership that is fit-for-purpose and positioned for optimal performance.

Clinical Development 94

Clinical Development Drug Development Clinical Research Drugs 94

Codon

APRIL 24, 2025

About one-fourth of all clinical trials and early drug development now happens in China. regulators hoping to speed up drug development, too. Impacts from China’s reforms can be seen by looking at clinical trial enrollment data. “China’s Clinical Trial Boom.” Cite: Jain, H.

Clinical Trials 125

Clinical Trials Trials Pharmaceutical Companies Licensing 125

Perficient: Drug Development

JANUARY 24, 2025

Knowledge Management & Clinical Research The exponential growth of medical knowledge presents both challenges and opportunities for acute care providers. GenAI can serve as a powerful tool for knowledge management and clinical research, enabling healthcare organizations to stay at the forefront of evidence-based practices.

Compliance 52

Compliance Hospitals Clinical Research Science 52