Clinical Pharmacology, Compliance and Pharmaceuticals

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Understanding the Regulatory Environment in Japan for Generic Drug Development

Drug Patent Watch

DECEMBER 30, 2024

This article aims to provide a comprehensive overview of the key aspects of the regulatory framework, highlighting the requirements and challenges faced by pharmaceutical companies seeking to introduce generic drugs into the Japanese market. Clinical Pharmacology & Therapeutics , 111(3), 531538. Freyr Solutions.

Drug Development

Drug Development Clinical Pharmacology Clinical Trials Pharmaceutical Companies

Angel Reyes Joins Altasciences as General Manager of CDMO Services

Alta Sciences

OCTOBER 5, 2023

He brings to Altasciences over a decade of experience in management and supervisory roles for manufacturing operations and supply chains, having demonstrated an impeccable standard in ensuring adherence to compliance and cGMP policies.

Clinical Pharmacology

Clinical Pharmacology Compliance Drug Development Pharmaceuticals

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Bridging Innovation & Patient Care: The Growing Role of AI

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Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Agency IQ

JUNE 2, 2023

AgencyIQ’s guidance agenda tracker FDA published a draft guidance document proposing a 180-day enforcement period for dietary supplement products to come into compliance with requirements that all New Dietary Ingredients be listed. Comments on the proposal closed on July 19. Once published, the 180-day amnesty period will start.

FDA

FDA Science Regulations Production

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Bridging Innovation & Patient Care: The Growing Role of AI

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Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Agency IQ

FEBRUARY 12, 2024

Accelerated Approval of Drugs and Biologics Administrative/ Procedural New Civil Monetary Penalties for Failure to Meet Accelerated Post Marketing Requirements Administrative/ Procedural Carried over from previous guidance agenda Exclusivity for First Interchangeable Biosimilar Biological Products Administrative/ Procedural Carried over from previous (..)

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

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.

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

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 (..)

FDA

FDA Science Regulations Clinical Trials

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

JUNE 16, 2023

There would also be cost savings to both FDA and industry from facilitating the review of documentation that ensures compliance with our regulations prior to being allowed to enter the United States. This action is being undertaken to revise regulations that required paper submission in duplicate, triplicate, etc.

Regulations

Regulations FDA Science Production

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Agency IQ

FEBRUARY 15, 2024

These topics include administrative, advanced manufacturing, the Animal Rule, antimicrobials, biosimilars, blood products, breakthrough devices, cell and gene therapy products, CGMP, clinical pharmacology, clinical trials, clinical/medical guidance, combination products, communication, compounding, cybersecurity, device software, digital health technologies, (..)

FDA

FDA Science Biosimilars Clinical Trials

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Agency IQ

SEPTEMBER 29, 2023

October 2023 Amendments to the Final Rule Regarding the List of Bulk Substances That Can Be Used to Compound Drug Products in Accordance With Section 503A of the Federal Food, Drug, and Cosmetic Act (Proposed Rule) FDA has issued a regulation creating a list of bulk drug substances (active pharmaceutical ingredients) that can be used to compound (..)

FDA

FDA Science Regulations Production

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Agency IQ

FEBRUARY 2, 2024

Legal Deadline March 7 Considerations for the Development of CAR T Cell Products FDA CBER March 15 Patient Listening Session: Patients with ADHD FDA March 22 Patient Listening Session: Patients with ADHD FDA March 25 Deadline to participate in the Quality Management Maturity Program Pilot.

FDA

FDA Science Clinical Trials Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Agency IQ

MARCH 1, 2024

EPA March 1 FDA Budget FDA’s budget authority will expire as of midnight on March 1 POLITICO March 5 Lawsuit (Vanda vs. FDA) FDA required to have resolved dispute with Vanda Pharmaceuticals or hold a hearing. The following PDUFA dates were obtained from publicly available sources.

FDA

FDA Science Clinical Trials Regulations

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

Agency IQ

DECEMBER 1, 2023

12/29/2023 FDORA, Section 3602 Clinical Trials Modernization : FDA is directed to require the submission of a “diversity action plan” for all Phase 3 clinical trials of new drugs. and Annex 1 Conference Joel Welch December 12 AgencyIQ Looking ahead to 2024: Regulatory Forecast for the U.S. Comments on the proposal closed on July 19.

FDA

FDA Science Regulations Production

FDA’s Project Optimus: A new era in oncology drug dosing

Drug Target Review

JANUARY 20, 2025

These advances are reshaping how pharmaceutical and biotechnology companies approach clinical trial design, with a focus on patient-centric dosing strategies. This article explores how innovations in precision medicine are reshaping clinical trials, followed by a discussion on Project Optimus and its impact on dose optimisation.

Clinical Trials

Clinical Trials Trials Drugs Drug Development

Beyond ELISA: the future of biomarker validation

Drug Target Review

NOVEMBER 27, 2024

11 Pharmaceutical companies are increasingly outsourcing due to resource and capacity constraints, the need for specialised expertise, and the flexibility outsourcing offers in project management. Clinical Pharmacology & Therapeutics. Outsourcing Biomarkers in Clinical Trials: Advantages and Disadvantages. 174-177.

Drug Development

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Drug Discovery Digest

Understanding the Regulatory Environment in Japan for Generic Drug Development

Angel Reyes Joins Altasciences as General Manager of CDMO Services

Webinars

Trending Sources

Analysis Life Sciences Thank You What We Expect the FDA to do in June 2023

Webinars

Analysis Life Sciences Thank You A closer look at CDER’s new 2024 guidance agenda

Analysis Life Sciences Thank You What We Expect the FDA to do in November 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in May and June 2024

Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Analysis Life Sciences Thank You 166 guidance documents the FDA is actively working on in 2024 (and beyond)

Analysis Life Sciences Thank You What We Expect the FDA to do in October 2023

Analysis Life Sciences Thank You What We Expect the FDA to do in February and March 2024 (Updated)

Analysis Life Sciences Thank You What We Expect the FDA to do in March and April 2024

Analysis Life Sciences Thank You What We Expect the FDA to do in December 2023

FDA’s Project Optimus: A new era in oncology drug dosing

Beyond ELISA: the future of biomarker validation

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