Regulatory Oversight

Peter Stein, MD will present FDA’s keynote presentation at the CPhI North America conference on Thursday, April 26, 2018 in Philadelphia, PA.

Certificates of analysis can be used to monitor the reliability of products and their suppliers, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Accelerated development of new preventives raises challenges for efficient CMC evaluation and production.

Implementing electronic batch records can offer a means of compliance, reduction in errors, streamlined ability to trace actions, and simultaneous generation of documentation.

The agency’s Committee for Medicinal Products for Human Use recommended six drugs for approval at its March 2018 meeting.

The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.

The agency sent a warning letter to Malladi Drugs & Pharmaceuticals Limited after an inspection found CGMP violations that included the presence of vermin.

The agency published two new guidance documents detailing postmarketing safety reporting requirements for combination products.

The European Medicines Agency has published a new tool that gives a transparent overview of the agency’s relocation to Amsterdam.

The agency announced proposed research studies on how healthcare providers and patients understand drug promotional materials.

The delivery device and drug form should be considered when choosing a test method for identifying and measuring particulates.

A previously published article presented difficulties with the revised European guidelines on sterile manufacturing. The authors included a brief summary of the comments developed on the draft document. This article expands upon that summary, outlines the authors' rationale, and highlights the most difficult aspects of the revision draft.

Revisions to chapters on glass containers and elastomeric closures were canceled following review of comments.

The European Medicines Agency has called for the immediate suspension and recall of AbbVie and Biogen's multiple sclerosis drug Zinbryta (daclizumab beta).

This article presents considerations for preventing hazards associated with dust in pharmaceutical production, particularly as relates to the United Kingdom's Control of Substances Hazardous to Health (COSHH) Regulations.

This article describes a new, combined, quantitative method for assessing excipient risks that has been developed by the authors as one possible risk evaluation method.

In-house experts can help select the right systems and suppliers, making validation and compliance easy, says Siegfried Schmitt, principal consultant at PAREXEL.

FDA enforcement efforts and drug approvals trend upward.

Drug companies must consider all factors impacting the cost of drugs, including high costs of early development stages.

Robert Iser of PAREXEL Consulting answers questions regarding the regulatory expectations of quality agreements and how companies can ensure the quality and safety of their products.

The agency clarifies recommendations found in ICH Q11 about chemical entities and biotechnology entities.

The agency released draft guidance on the format for electronic submissions of NDA and BLA content regarding the planning of bioresearch monitoring inspections.

FDA Commissioner Scott Gottlieb issued a statement that FDA will be modernizing regulatory programs in order to advance novel treatments.

The agency provides information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms.

The guidance addresses the development, analysis, and presentation of microbiology data during antibacterial drug development.

The agency met to discuss its new temporary and permanent premises in Amsterdam.

Steve Hayward, product marketing manager at BIOVIA, Dassault Systèmes, discusses the importance of both technology and people in the modern laboratory.

This article explores lab data integrity violation trends, as well as a sampling of the latest technologies that can help avoid them.

Greater clarity and harmonization in ATMP regulations are needed to promote the development and commercialization of these therapies.

Regardless of the phase of development and the level of GMPs being applied, there should be adequate controls and knowledge to assure patient safety, according to Susan Schniepp, fellow at Regulatory Compliance Associates.