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In the months since US and EU authorities restricted Zhejiang Huahai’s market access over the discovery of nitrosamine impurities in its valsartan API, the broader regulatory consequences for drug manufacturers are coming into focus.
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FDA Launches Pilot To Gain Practical Experience With 'Established Conditions' In Quality Assessments
FDA is accepting applications from the pharmaceutical industry to pilot the use of established conditions proposed by sponsors in NDAs, ANDAS, BLAs and supplements. The purpose of the pilot is for FDA to gain practical experience in assessing proposed established conditions and to ensure that assessment decisions do not negatively impact user fee time frames.
A deal on the European supplementary protection certificate manufacturing waiver has been agreed by the European Council, Parliament and the European Commission, providing a concrete path for a regulation to move forward, albeit with compromises on several key provisions. Meanwhile, the European off-patent and brand industries remain at odds over the benefits of the waiver.
Biotech firm chooses words carefully to wind its way through site inspection findings and CMC review concerns in hopes of winning its first FDA approval for a breakthrough breast cancer treatment.
FDA’s drug center has proposed a new program that would allow pharmaceutical manufacturers to attest that drug products submitted for review conform to certain consensus quality standards. The agency said that such a program would improve drug quality, encourage the development of emerging technology and ensure smoother drug reviews.
The US drug regulator may now rely on a total of 22 EU member states whose inspection results can replace its own inspections.
The government has said it is prepared to discuss the terms of supplementary protection certificates under a UK-only regime if there is a no-deal Brexit, but concerns also linger over the start dates for regulatory data protection.
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