GMP News - Pharmaceutical Development / Clinical Trials / GCP

02.11.23

USP Briefing on Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins

Publications in the'USP Proposals PF 49_5 also include a draft chapter <1060> "Mass Spectrometry-Based Multi-Attribute Method for Therapeutic Proteins".

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26.10.23

Revised USP Chapter <660> Glass Containers

Following the previously issued draft for USP General Chapter <660> Containers – Glass, the final version of the chapter was published and made official on 1st October 2023. In particular, the revision to General Chapter <660> changed the "composition based" glass type definition to one that is "performance based".

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26.10.23

Quality Attributes for Ophthalmic Drug Products

The FDA published a draft guidance that discusses quality considerations for ophthalmic drug products (i.e., solutions, suspensions, emulsions, gels, ointments, and creams) intended for topical delivery in and around the eye.

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26.10.23

EMA Publishes revised CTIS Transparency Rules

The EMA has endorsed the revised transparency rules for the EU Clinical Trials Information System (CTIS). According to the agency, the simplifications introduced will give access to clinical trial information to stakeholders, patients and healthcare professionals in a faster and more efficient way.

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26.10.23

Key Factors for Compassionate Use

The FDA published a draft guidance for institutional review boards (IRBs) and clinical investigators regarding the key factors and procedures IRBs should consider when reviewing individual patient expanded access submissions (IPEAS).

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26.10.23

FDA's final Guidance on Real-World Data and Real World Evidence

The U.S. Food and Drug Administration (FDA) issued the final guidance for the Use of Real-World Data (RWD) and Real-World Evidence (RWE) to support regulatory decision-making for drugs and biological products. What are the sponsor's responsibilities?

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04.10.23

New USP Chapter: Wetting Properties of Pharmaceutical Systems

An expert group of the US Pharmacopoeia (USP) is working on a new chapter on wetting properties of pharmaceutical systems, which may have relevance for both batch and continuous manufacturing. The draft can be found in Pharmaceutical Forum PF49(5).

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28.09.23

Annual Report Forms for Postmarketing Requirements

The FDA published the final guidance on annual status reports and other submissions for postmarketing requirements (PMRs). The reports are intended to facilitate submissions by drug and biological product application holders of complete and accurate information on PMRs and postmarketing commitments (PMCs) in a consistent format.

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28.09.23

FDA issues Final Guidance on Informed Consent

The U.S. Food and Drug Administration (FDA) issued the final document, "Informed Consent: Guidance for IRBs, Clinical Investigators, and Sponsors". Amongst others, the guidance clarifies who is responsible for the specific areas related to informed consent that should be considered.

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28.09.23

How to Obtain Data on Populations Underrepresented in Clinical Trials

The FDA has published a draft guidance entitled “Postmarketing Approaches to Obtain Data on Under-Represented Populations in Clinical Trials”. The purpose of this document is to describe FDA requirements and provide recommendations for obtaining safety and effectiveness information on drug and biological products in the postmarketing setting in typically under-represented patient populations in clinical trials.

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28.09.23

EMA's Expectations for updated Investigator's Brochures and Informed Consent Forms

What are the expectations for distribution of updated Investigator's Brochures (IBs) and updated Informed Consent Forms (ICFs) to clinical sites / investigators?

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28.09.23

GCP Inspection Reveals Deficiencies at CRO in India

Critical inspection findings at a study center in India led the European Medicines Agency (EMA) to launch a referral process and to review potential implications for marketing authorizations in Europe. This followed a GCP inspection by the Spanish Agency for Medicines and Medical Devices (AEMPS), which raised serious concerns about the validity and reliability of the study data generated by the CRO.

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26.09.23

WHO issues draft Guidance on Best Practices for Clinical Trials

The World Health Organization (WHO) published a draft guideline on best practices for clinical trials. The document is intended to provide guidance to WHO’s Member States and any staff members of non-State actor organizations whose work is related to clinical trials.

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26.09.23

New EMA Reflection Paper on the use of Artificial Intelligence

On 19 July 2023, the EMA (European Medicines Agency) published a Reflection Paper on the use of Artificial Intelligence (AI) in the medicinal product  lifecycle. This document is open for comments until 31. December 2023. What is the content of the document?

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12.09.23

Critical Quality Attributes for Topical Dosage Forms

A recently issued USP stimuli article describes advances in product quality and performance tests for topical and transdermal delivery systems (TDS). In particular, the article focuses on physicochemical and structural characterization tests for semisolid drug products.

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