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February 06, 2019
The agency is requiring companies that make sartan blood pressure drugs to review their manufacturing processes due to the problem with impurities.
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.
February 04, 2019
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.
February 02, 2019
As we approach the next instalment of Pharmapack Europe, a potentially perilous situation in relation to drug packaging has emerged for pharmaceutical companies should Brexit result in a ‘no deal’ scenario.
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.
Robotic isolators and single-use technologies are gaining ground, according to aseptic processing consultant Jim Agalloco.
Political instability is causing uncertainty in Europe and wreaking havoc with US regulatory timeframes.
Novel analytical methods may help biologics manufacturers respond to stricter regulations on particulate matter.