Quality/GMPs

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.

A properly designed validation program will detect variation and ensure control based on process risk.

As automation in biomanufacturing becomes more important, so does the need to integrate process data.

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

The USP Quality Institute’s third fellow in its Fellowship in Quality Medical Products program will study the role of poor-quality medicines in fostering antimicrobial resistance.

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

The two countries have been included in the mutual recognition agreement between the EU and US for GMP inspections.

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

The drug is approved in the United States specifically for treating acquired thrombotic thrombocytopenic purpura, a rare blood-clotting disorder.

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.

Supply chain players are eligible to participate in FDA’s pilot program to develop an electronic system for tracking drug products.

The US District Court for the Western District of Pennsylvania entered into a consent decree of permanent injunction against Ranier’s Rx Laboratory Inc., a compounding facility.

The agency recommended six medicines for approval at its January 2019 meeting, including treatments for lung cancer, HIV-1, and autoimmune disorders.

The US Pharmacopeial Convention’s new plan will include new and revised quality standards and activities to support the development of new generic drugs.