Quality/GMPs

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.

Radha Iyer, vice-president and head of Quality and Scientific Affairs, Global Developed Markets, Dr. Reddy’s Laboratories, discusses new initiatives at the company.

New HHS proposal would remove the current safe harbor protection from the federal Anti-Kickback Statute for rebates or discounts provided to Medicare Part D drug plans and certain state Medicaid programs.

Getting to the root of the cause can prevent future problems, says Susan Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.

Policies emphasize the importance of ensuring data integrity in the United States and abroad.

To ensure the sterility of parenteral biopharmaceutical products, it is necessary to employ certain tools, technologies, and standard operating procedures.