Quality/GMPs

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.

A look at the skill sets and training needed to tackle the increasing levels of automation in bioprocessing facilities.

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

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.

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 companies aim to assess automated CAR-T cell therapy manufacturing at the point-of-care and develop technologies to facilitate patient access to immunotherapies.

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.

The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.

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

Ned Sharpless is tapped to take on acting commissioner role following Gottlieb’s resignation.

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

OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).

The new automated cloud-based tool allows for the design of targeted single-cell DNA custom panels.

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

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

The FDA commissioner plans to leave the agency in April.

Jessica Rousset, chief operating officer, CURE Pharmaceutical, highlights some key regulatory considerations developers should keep in mind when approaching alternative dosage forms.

In light of recent FDA guidance on data integrity, the challenges and benefits of using the public cloud to deploy and use data management software are discussed.

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.