Regulatory Oversight

When considering whether to outsource work to a CRO, there are a number of factors to assess, including the type of work that may be outsourced, regulatory considerations, and needs for the study.

EMA has been assigned a formal role in preparing for and managing future public health crises within the EU through the formalization of ad-hoc structures and processes that were employed during the COVID-19 pandemic.

FDA will use virtual site visits even after resuming active inspections.

FDA continues efforts to incentivize drug manufacturers to follow higher data integrity requirements.

A new initiative aims to speed the approval of and access to new drugs for young patients around the world, while limiting the number of children needed for testing in clinical trials.

AstraZeneca's recombinant COVID-19 vaccine, originally invented by the University of Oxford, has been approved as a third dose booster vaccine in the EU.

EMA has recommended the marketing authorization of Xenpozyme (olipudase alfa) in the European Union.

Several steps need be taken to achieve lights-out, fully automated operations.

The agency’s Center for Drug Evaluation and Research has launched the new program to increase development of treatment options for patients with rare diseases.

The draft guidance describes the benefit-risk principles used to conduct product quality-related assessments of CMC information submitted to FDA for assessment as part of NDAs, BLAs, or supplements.

In this episode of Drug Digest, Pharmaceutical Technology editors, Felicity Thomas and Feliza Mirasol, examine the topic of emerging therapies in more detail, covering subjects such as the challenges of scale, the potential benefits of drug delivery innovation, importance of early analytical studies, the evolution of the regulatory landscape, and differences between regional regulatory requirements.

The guide reviews unit operations and establishes equipment requirements for continuous manufacturing of oral solid dosage forms.

FDA’s Office of Compliance has released its 2021 Annual Report, which highlights the agency’s successes in public health.

Establishing a quality culture from the top of an organization down to each and every employee ensures a safe and effective product, and saves costs.

Recent trends in dissolution testing have led to increased use of data integrity solutions and more biorelevant testing techniques.

The move toward using the Digital Application Dataset Integration (DADI) project for the initial implementation of IDMP-based regulatory data submissions offers both opportunities and challenges for pharmaceutical organizations.

On 26 May 2022, the European Commission will roll-out the new in-vitro diagnostic regulation.

Process validation for a drug product must be done with commercial scale batches, says Siegfried Schmitt, vice president, Technical at Parexel.

Pharmaceutical Technology asked Jeff Elton, PhD, CEO of ConcertAI, about the role technology plays in performing CAPAs.

Performing corrective action and preventive action (CAPA) activities is often necessary to investigate a manufacturing deviation and prevent it from reoccurring. Pharmaceutical Technology asked Joe O’Gorman, head of Global Operations at LZ Lifescience, a Cognizant Company, about the role technology plays in performing CAPAs.

Data may be used to improve (or remove) a corrective action/preventive action.

In January 2022, Europe started to implement EU-CTR, a new regulatory framework for clinical trials, but what does this mean for pharma clinical research?

Quality metrics and more domestic production aim to avoid supply disruptions and drug shortages.

Pharma’s interest in decentralized clinical trials (DCTs) increases as it helps to expand their geographical reach and racial diversity

Testing cleanroom garments while in use and during daily cleanroom operations is vital for contamination control.

Why critical thinking must be applied before technology to ensure regulatory compliance.

This article discusses select industry experience with regulatory authorities utilizing alternative mechanisms for assessing compliance as part of their review and approval of existing marketing authorizations or new applications.

EMA’s PRIME scheme has enabled life-changing medicines to become available to patients at a faster rate.

Process performance metrics of eight different mechanical devices were assessed to evaluate compliance with regulatory and compendial criteria.

A consensus-based approach to GDP lies at the heart of a new industry-wide program seeking to rationalize, standardize, and harmonize the adherence to pharma transportation norms and regulatory guidelines.