Regulatory Oversight and Compliance

Novartis’ Sandoz is seeking approval of its biosimilar referencing Johnson & Johnson’s Remicade (infliximab) for all of Remicade’s indications across gastroenterology, rheumatology, and dermatology.

EMA has recommended approval of the biosimilar for the same indications as Roche’s Herceptin (trastuzumab).

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The draft guidance addresses the agency’s policy on evaluating bulk drug substances in drug compounding.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’s Clinical Data Summary Pilot program will post redacted Clinical Study Reports in order to help stakeholders understand why FDA approved a new drug application.

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).

The FDA commissioner outlined the agency's initiatives to reward innovation and biosimilars development.

The agency has approved a new HIV treatment for patients with "limited treatment options".

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.

The upcoming serialization deadline and the United Kingdom's departure from the European Union could result in supply bottlenecks.

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.

Manufacturers face demands for timely information on clinical studies, product recalls, and approvals.

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.

Divinity Products Distribution of Grain Valley has voluntarily agreed to destroy and recall kratom-containing dietary supplements as part of FDA's crackdown on the plant.

FDA and CDC are investigating a multi-state Salmonella outbreak that appears to be caused by kratom, a plant used as an opioid substitute.

The agency has approved a new treatment for a certain type of prostate cancer using novel clinical trial endpoint.

FDA approves Vertex's cystic fibrosis drug, Symdeko (tezacaftor/ivacaftor and ivacaftor), which is made using a continuous manufacturing process.

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