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November 02, 2018
A London-based pharmaceutical company has been charged with offences relating to the nature and quality of medicinal product used for parenteral nutrition in babies.
Building up relevant expertise in-house will make writing spec sheets for software easier, according to Siegfried Schmitt, principal consultant at PAREXEL.
Experts share best practices, and war stories, for a crucial but often underappreciated part of drug development.
New FDA guidance offers a time buffer but increases supply-chain-management complexity, as active DSCSA enforcement begins.
October 31, 2018
A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.
Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.
October 24, 2018
A federal court judge ordered Keystone Laboratories, Inc. of Memphis, Tennessee to stop selling over-the-counter drug products.
October 23, 2018
The agency, in partnership with international regulatory and law enforcement agencies, cracked down on 465 websites marketing illegal opioids and other drugs claiming to treat conditions such as cancer and HIV.
Promise Pharmacy recalls one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3mL vials due to particulates in the solution.
October 19, 2018
The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indication.