Alta Sciences

JULY 25, 2024

Watch the poster presentation. TOP MANUFACTURING AND ANALYTICAL SCIENTIFIC RESOURCES Podcast: Successful Manufacturing of Clinical Trial Supply Join our formulation and pharmacy experts as they share insider secrets for overcoming clinical trial challenges and resolving issues that could impact your drug development program's timeline.

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Alta Sciences

OCTOBER 30, 2023

36: Nonclinical Studies in Cell and Gene Therapy – Key Considerations and Regulatory Guidance With an estimated 6,000 monogenic diseases affecting over 350 million people worldwide, the advantages of cell and gene therapy can be a ray of hope—but development of complex, leading-edge therapies requires careful planning. Read it now.

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Agency IQ

MAY 3, 2024

Title Type Comments Close Key Information and Facilitating Understanding in Informed Consent Guidance for Sponsors, Investigators, and Institutional Review Boards Draft Guidance April 30 Early Alzheimer’s Disease: Developing Drugs for Treatment Draft Guidance May 13 Select Updates for the Premarket Cybersecurity Guidance: Section 524B of the (..)

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Agency IQ

SEPTEMBER 15, 2023

According to the FDA’s agenda, linked above, and the meeting minutes , Leslie Hendeles, Randy Hatton, and Jonathan Shuster of the University of Florida gave presentations supporting the assertions they had made in their petition. CHPA supplemented the FDA’s presentation on retail volume with survey results on consumer preferences.

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Metabolite Tales Blog

JULY 5, 2023

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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Metabolite Tales Blog

JULY 5, 2023

However, in the quest to tackle challenging disease targets with difficult drug binding sites, there is revived interest in developing this compound type to offer unique solutions. Current macrocycles in clinical use generally focus on treatment of infectious diseases, cancer and auto-immune disorders.

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Agency IQ

DECEMBER 11, 2023

Diagnostic and therapeutic advances in oncology have moved many cancer types into the categories of curable or treatable diseases. OCE leadership and staff also kept AgencyIQ staff very busy in 2023 as they attended and presented at countless meetings. months, according to the GSK presentation.

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Agency IQ

SEPTEMBER 29, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

JULY 28, 2023

According to the notice, the contract includes at least three deliverables: (1) an internal report or presentation to FDA, (2) a public workshop with stakeholders using data collected and published in the Federal Register Notice, and (3) a summary of the public workshop and recommendations to inform potential updates to FDA’s guidances.

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Agency IQ

JUNE 2, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

OCTOBER 27, 2023

Government shutdown: At present, the U.S. While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. federal government has appropriated funding through November 17.

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Agency IQ

JULY 8, 2024

12/29/2023 FDORA, Section 3202 Rare Diseases: GAO to release a report to Congress assessing the policies, practices, and programs of the FDA with respect to the review of applications for approval of drugs and biologics intended to treat rare disease, with a focus on the effectiveness of FDA’s policies and challenges encountered by sponsors.

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The Anticancer Fund

JUNE 7, 2022

Please get in touch if you’re interested in discussing research based on the findings presented below ( info@anticancerfund.org ). All articles need to be critically assessed and viewed in their broader research context.

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Agency IQ

FEBRUARY 23, 2024

In between, panelists and presenters also discussed alternative designs for dose-finding trials and creative strategies for evaluating and modeling early clinical data. I’m not going to say which one is better,” said JIANG LIU, scientific lead at the FDA’s Division of Pharmacometrics in the Office of Clinical Pharmacology.

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Agency IQ

JUNE 16, 2023

Prescription drug advertisements presented through media such as TV and radio must disclose the product’s major side effects and contraindications in what is sometimes called the major statement. This rule also establishes standards for determining whether the major statement in these advertisements is presented in the manner required.

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Agency IQ

FEBRUARY 2, 2024

Government shutdown: At present, the FDA has appropriated funding March 1. EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

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Alta Sciences

JULY 31, 2024

Why Diversity in Clinical Trials Matters A wide variety of factors, from age or biological sex to environmental conditions and lifestyle choices (e.g., substance abuse, sexual activity), can influence the risk and likelihood of developing a disease or other long-term health issues—as well as the way an individual responds to treatment.

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Agency IQ

DECEMBER 1, 2023

Government shutdown: At present, the FDA has appropriated funding through January 19. While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published.

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Agency IQ

MARCH 1, 2024

Government shutdown: At present, the FDA has appropriated funding lasting until midnight on Friday, March 1. District Court March 7 Guidance Expiration FDA’s Guidance on Assessing Covid-19-related symptoms in clinical trials of products intended to treat the disease expires.

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Agency IQ

FEBRUARY 15, 2024

If you’re looking for something specific, we recommend using the search function in your browser (Ctrl-F) to look for keywords of interest.

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FDA Law Blog: Drug Discovery

OCTOBER 28, 2024

Patient and population-specific considerations include an understanding of the background rates of specific long-term neurodevelopmental outcomes in the population of interest, and disease-specific characteristics that may increase the risk for adverse neurodevelopmental outcomes.

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Drug Target Review

NOVEMBER 27, 2024

Finally, its application in urine samples presents additional challenges compared to serum. 5 Alzheimer’s disease: driving advancements with precision medicine In contrast, advanced technologies like MSD and LC-MS/MS offer enhanced precision and sensitivity for biomarker analysis. Clinical Pharmacology & Therapeutics.

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Agency IQ

JULY 12, 2024

Specifically, FDA is proposing to classify blood irradiators intended for the prevention of transfusion-associated graft versus host disease into Class II and blood irradiators intended for prevention of metastasis by irradiating intra-operatively salvaged blood of cancer patients undergoing surgery into Class III.

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