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June 07, 2018
The agency is encouraging team-based reviews and streamlined processes that will make the oversight process more efficient and consistent.
June 06, 2018
The International Society of Pharmaceutical Engineering (ISPE) is field-testing the design principles of a comprehensive, industry-led program of self-evaluation of pharmaceutical quality that will align with the purpose of FDA’s quality metrics.
June 02, 2018
PDA reviews an industry survey of concerns and best practices regarding the EU GMP’s required PUPSIT test for filters used in sterile filtration.
Open communication channels between all the parties involved is key when outsourcing analytical methods, says Susan Schniepp, distinguished fellow at Regulatory Compliance Associates.
FDA and Congress seek to limit the production and distribution of pain medicines.
June 01, 2018
Pharmaceutical companies and their contractors are reorganizing their manufacturing lines and logistics to ensure compliance with the serialization requirements, but many SMEs are struggling to meet the deadline.
The company’s new UV-1900 UV-VIS spectrophotometer incorporates features that improve usability, regulatory compliance, and performance.
May 31, 2018
The agency published two guidance documents to address brand drug makers’ use of REMS to block generic-drug development.
May 30, 2018
The new draft guidance addresses the premarketing assessment of a drug’s effect on blood pressure.
FDA sent a warning letter to Jilin Shulan Synthetic Pharmaceutical Co., Ltd. after an inspection found CGMP violations including a lack of data integrity.