GMP News Drug Safety/Pharmacovigilance

24.08.23

FDA Issues First Draft Guidance on Clinical Trials with Psychedelic Drugs

The FDA issued a new guidance to provide general considerations to sponsors developing psychedelic drugs for medical use. According to the agency, there has been growing interest in the therapeutic potential of psychedelic drugs. This is the first FDA guidance that presents considerations for designing clinical trials for psychedelic drugs.

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24.08.23

Can Sponsors Contract Service Providers for Investigator Tasks?

The sponsor may support the investigator by contracting service providers. However, it is emphasized that the investigator is still responsible for any outsourced tasks.

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24.08.23

Can Productivity Applications be Used in Clinical Trials?

EMA's GCP Inspectors Working Group added a new Question & Answer relating to Productivity Applications in the section "GCP matters" of the Good Clinical Practice (GCP) Q&As. What are the Expectations for Productivity Applications used in Clinical Trials?

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23.08.23

Series of FDA Warning Letters due to inadequate Testing of Glycerin and Other High-Risk Drug Components

Just recently, we reported on a Warning Letter regarding a manufacturer who failed to conduct proper identity testing of glycerin and other high-risk components. The FDA has now published a whole series of Warning Letters that revolve around the same topic.

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17.08.23

GDP in the US: FDA Guidance on Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the FD&C Act

In the context of the Drug Supply Chain Security Act (DSCSA), the U.S. Food and Drug Administration (FDA) has announced the availability of a final guidance for industry entitled "Waivers, Exceptions, and Exemptions from the Requirements of Section 582 of the Federal Food, Drug, and Cosmetic Act."

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09.08.23

FDA's Draft Guidance on Postmarketing Noncompliance

The agency issued a draft guidance providing information for marketing authorization holders of human prescription drugs who are required to conduct postmarketing studies or clinical trials, commonly referred to as postmarketing requirements (PMRs). In case of PMR Noncompliance the MAH could be subject to an FDA warning letter.

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27.07.23

Remote Access to Study Data in Clinical Trials - What needs to be considered

EMA's GCP Inspectors Working Group added a new Question & Answer in the section on "Records of Study Subject Data Related to Clinical Trials" of the GCP Q&As. What are the considerations when direct remote access of health data is required in a clinical trial?

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27.07.23

FDA's Technical Conformance Guide for Study Data

The Technical Conformance Guide provides specifications, recommendations, and general considerations to sponsors and applicants on how to submit study data in a standardized electronic format.

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27.07.23

Adjusting for Covariates in Randomized Clinical Trials

The FDA has issued a new guidance together with a Guidance Snapshot which describes the agency's current thinking regarding adjusting for covariates in the statistical analysis of randomized clinical trials. According to the FDA, Sponsors should adjust for baseline covariates that are strongly associated with an outcome in a clinical trial population.

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27.07.23

ICH Update on GCP related Topics including RWD/RWE

Following the recently published  ICH E6(R3) Draft Guideline on Good Clinical Practice (GCP) the ICH announced progress on several new ICH Efficacy Guidelines including the publication of a new ICH Reflection Paper on Real-World Evidence / Real-World Data.

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25.07.23

Update on the EMA Guidance on Protection of Personal Data & CCI

The European Medicines Agency (EMA) plans to gradually resume clinical data publication from September 2023, having temporarily suspended this activity. Therefore, the EMA has revised and supplemented the previously published documents on the transfer of personal data and commercially confidential information (CCI) through the CTIS.

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25.07.23

Do you know DARWIN?

The EMA has published a document outlining a framework for establishing Real-world evidence (RWE) data in regulatory decision-making, based on the findings of some 30 studies initiated by the EMA and DARWIN EU®.

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04.07.23

EMA publishes Comments on ICH M11 CeSHarP

The EMA has updated its ICH M11 website to include overviews of comments received on the M11 draft documents. In particular, a huge number of comments were received from organizations relating to the ICH M11 template.

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04.07.23

Interim Guidance on Protection of Personal Data & Commercially Confidential Information

Following the previously published public consultation document on Data Protection of Information uploaded in the CTIS, the EMA has now published an interim guidance. The document is available for CTIS users and provides guidance on the protection of personal data and commercially confidential information (CCI) while using CTIS.

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04.07.23

Generally Accepted Scientific Knowledge in Drug Applications

The FDA has received an increasing number of questions regarding the extent to which generally accepted scientific knowledge (GASK) may be relied on for drug or biological product approval. Therefore, the agency published a draft guidance which describes instances in which it may be appropriate to rely on GASK to meet certain nonclinical safety requirements for new drug applications.

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