Regulatory/GMP Compliance

Knowing and addressing regulatory expectations early on can avoid unexpected delays later, says Siegfried Schmitt, principal consultant at PAREXEL.

FDA seeks more efficient testing to spur development of less costly biotech therapies.

Quality experts share insights on what the future may hold regarding regulatory quality requirements for biopharmaceuticals.

BioPharm International asked an FDA spokesperson how the agency plans on handling these issues in the future.

FDA sent a warning letter to Henan Lihua Pharmaceutical Co. Ltd. after inspectors found the company failed to ensure the accuracy of its data.

The agency published guidance about requests for Prescription Drug User Fee Act waivers, refunds, and reductions in user fees.

The agency launched a secure online portal for orphan drug designation applications.

FDA, EMA, and senior officials from the European Commission met to discuss the EU-US mutual recognition agreement for inspections, the development of advanced therapies, the requirements for approving generic drugs, and Real-World Evidence used for post-authorization monitoring.

The contract development and manufacturing company has received an additional approval from Health Canada to manufacture monoclonal antibody drug substance at its first plant in Icheon, South Korea.

Legislators have requested that FDA do more to prevent drug shortages.

An understanding of the unique nature of single-use systems, and how they interact with each biomanufacturing process, is important when qualifying single-use systems.

Industry experts discuss how to address extractables and leachables in single-use systems and the challenges in qualifying equipment.

Regulatory authorities have published draft guidance on strategies to facilitate pharmaceutical lifecycle management.

The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.

The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.

The FDA commissioner announced proposed steps to modernize the organization and functions of CDER’s Office of New Drugs.

Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.

Validation ensures safe and effective biologic products that benefit the patients whose health and wellbeing depend on the therapies.

FDA and Congress seek to limit the production and distribution of pain medicines.

The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.

FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.

This marks the third FDA approval for the company’s second biomanufacturing plant in Incheon, Korea.

Right-to-Try bill sent to White House for President’s signature after passage by Congress.

Representatives from the two pharmacopeias held a symposium on European and Indian legislation and regulatory requirements regarding the quality of drugs.

FDA sent a warning letter to Goran Pharma Private Limited citing inadequate quality control violations.