Regulatory/GMP Compliance

FDA is supporting the development and marketing of OTC therapies, including CBD products, by proposing new rules and an expanded review office and promoting digital technologies.

The guidance discusses the design and evaluation of comparative analytical studies used to support the biosimilarity of a proposed therapeutic protein product to a reference product licensed under section 351(a) of the Public Health Service Act.

Violations found by FDA included a failure to test product for API identity and strength, failure to validate outsourced materials, and a lack of written cleaning procedures.

Inspectors found a lack of control over computer systems and a failure to follow equipment cleaning and maintenance procedures.

The agency updated its list of recommended influenza virus strains that manufacturers should include in vaccines for the autumn 2019 season.

TraceLink will participate in the agency’s Pilot Project Program under the Drug Supply Chain Security Act.

The European Medicines Agency has issued a vacancy notice for the position of executive director.

The guidance will assist sponsors in demonstrating a proposed therapeutic protein product is interchangeable with a reference product.

While the multiple attributes method gains ground and traditional lab methods improve, broad efforts are underway to determine biopharmaceuticals’ most significant critical quality attributes and enable real-time release.

New agency leadership is pressed to promote innovation while addressing safety and quality issues.

Delays in revisions to guidelines by the European Union are impeding the pharmaceutical industry.

The company’s center of excellence for advanced analytical testing passed GMP inspection from the European Medicines Agency.

The company passed a seven-day FDA surveillance GMP inspection and announced two upcoming manufacturing partnerships.

The agency provides recommendations for the development of bispecific antibody development programs that include regulatory, quality, nonclinical, and clinical considerations.

AstraZeneca and MSD have announced the EC's approval of Lynparza (olaparib) as a monotherapy in the treatment of advanced or metastatic breast cancer.

Novartis has announced that FDA has accepted its biologics license application (BLA) for brolucizumab (RTH258) for the treatment of wet age-related macular degeneration (AMD).

Sharpless will seek further solutions to the opioid crisis and work to reduce cigarette use in adults and kids.

FDA sent a warning letter to RIJ Pharmaceutical LLC after an inspection of the company’s Middletown, NY facility found CGMP violations.

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.