Regulatory/GMP Compliance

The agency sent a warning letter to Luen Fook Medicine Sdn., Bhd. for CGMP violations found at the company’s Malaysia facility.

EMA is evaluating the safety of Lemtrada (alemtuzumab) after new side effects were reported.

At INTERPHEX 2019, CEO Richard Johnson highlighted the importance of PDA’s new Asian business unit and outlined the organization’s plans. Data integrity guidance for manufacturing and quality systems will be published by the end of the year, as efforts move into big data and artificial intelligence.

In a keynote session at INTERPHEX 2019, experts will review and debate the issues and present potential solutions for contamination issues in aseptic manufacturing.

A robust customer complaint handling system is an integral part of a quality management system, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

FDA is moving to shift industry away from step-wise batch production.

Globally accepted products are becoming increasingly in demand, leading to more need for regulatory harmonization, particularly for biosimilars.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.

The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.

The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.

FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.

Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.

FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.

The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.

Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.

FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.

Both empty and filled syringes must pass a range of tests to meet quality standards for biopharmaceutical drugs.

Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

The agency clarified the process for development programs for regenerative medicine therapies.

The guidance explains the process of applying for competitive generic therapy designation.

A taskforce evaluated the advantage of using Big Data in the evaluation of the benefits versus risks of medications.

FDA came away with the largest boost in its annual budget in a decade as part of the final spending package approved by Congress this week.

In January 2019, a temporary measure reopened the US government until Feb. 15, 2019, allowing FDA to resume full operations. Failure to find a permanent solution could have dangerous ripple effects on patient safety and innovation, says Jim Nolan, CEO of InClinica.