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November 27, 2018
FDA has issued a warning letter to Mylan citing GMP violations of finished pharmaceutical products manufactured at the company’s Morgantown, WV, facility.
November 14, 2018
The agency sent a warning letter to the company for marketing an unapproved stem cell product and CGMP violations.
November 12, 2018
The agency is developing a new way to assess, record, and report data from surveillance and preapproval inspections of sterile drugs.
November 06, 2018
An ERP solution provides for the management of multiple business activities and traceability requirements resulting from regulations, customer demands, sourcing, and international business needs.
November 02, 2018
Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.
This paper describes how the concept of acceptance value can be redefined to remove bias and more closely reflect quality targets.
Experts share best practices, and war stories, for a crucial but often underappreciated part of drug development.
October 31, 2018
Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.
October 23, 2018
Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.
Promise Pharmacy recalls one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3mL vials due to particulates in the solution.