Regulatory/GMP Compliance

The Yale School of Public Health’s regulatory sciences program expansion builds on the current regulatory affairs track program, which focuses on the administrative, policy, and legal aspects of product regulation.

As recent COVID-19 vaccine facility citations make clear, failure to meet cleaning and sanitization requirements puts patients, facilities, and operators at risk.

White House proposal includes measure to make drugs more affordable.

HHS is tasked with establishing a public-private consortium for advanced domestic pharmaceutical production.

Regulatory inspection reports can be a valuable resource for quality management, according to Siegfried Schmitt, vice president, Technical at Parexel.

FDA's CDER has launched an initiative to gain more efficient and transparent operations of its advisory panels.

The guidance provides recommendations for including premenopausal women in breast cancer clinical trials.

The final guidance document is intended to help determine which reporting category is appropriate for a change in CMC information to an approved biologics application.

The agency approved two batches of drug substance manufactured at the Emergent BioSolutions facility in Baltimore for use in the Janssen COVID-19 vaccine.

The new site in Monts, France, which is operated by Recipharm, will produce finished COVID-19 vaccine product.

Immodulon has received an indication of allowability from the European Patent Office for the claims in its patent application relating to its lead drug candidate.

The agency issued two final and two draft guidance documents to help identify and trace drug products in the supply chain.

The Biden administration supports a notable increase in funding for public health and research as a lead priority for the coming year.

Expanded interest in advanced drug manufacturing and continuous production methods calls for more flexible production systems and regulatory policies.

Susan J. Schniepp, distinguished fellow at Regulatory Compliance Associates, answers some commonly asked questions about regulatory filings.

FDA recently published a final guidance for making post-approval manufacturing changes to drugs and biologics, the culmination of a long-running effort to facilitate improvements in medical product quality through the product life cycle.

The guidance provides a framework for the management of postapproval chemistry, manufacturing, and controls changes.

The guidance document gives recommendations to support biopharmaceutics classification of drug substances and the Biopharmaceutics Classification System-based waiver of the in-vivo bioequivalence study requirement for drugs.

The agency has published multiple guidance documents and policy initiatives for updating and advancing the clinical research process.

The agency’s human medicines committee has recommended extending the approved storage period of unopened thawed vials at 2–8 0C from five days to 31 days.

The COVID-19 pandemic has triggered additional considerations to supplier oversight of contract manufacturing facilities.

FDA expects to conduct only a small portion of scheduled facility visits in 2021 due to continued limitations on travel imposed by the COVID-19 pandemic.

The agency released a report that outlines inspectional activities conducted during the COVID-19 pandemic and discusses plans for future inspection operations.

Sandoz will soon begin enrolling patients with neovascular age-related macular degeneration in a Phase III study with its proposed biosimilar to aflibercept.

Combating COVID-19 is bolstering efforts to limit patent protections on innovative medicines and vaccines.

Bio/pharma can learn ways to prevent recurring events and ineffective CAPA from the nuclear power sector.

Updates to user fee programs that fund FDA operations are being finalized by industry stakeholders for approval by Congress.

A FDA report cites multiple ongoing violations that undermine assurance of quality in products from this plant and the need for a continuing “pause” in production.

Even before Emergent disclosed that it had to discard 15 million doses of the J&J vaccine drug substance, FDA inspectors had uncovered multiple deficiencies and quality control issues.

Scrutiny of the vulnerability in the biopharmaceutical supply chain has increased pressure on FDA to renew site visits of domestic and foreign facilities.