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Rep. Elijah Cummings (D-Md.) and Sen. Bernie Sanders (I-Vt.) are going after Teva, Mylan and Heritage Pharma again for allegedly obstructing a congressional inquiry into generic drug prices. Read More
The FDA is investigating the firm for failing to disclose problems with animal testing data until more than a month after the product was approved. Read More
Drugmakers were generally supportive but raised some questions and concerns in comments on the FDA’s draft guidance on increasing diversity in clinical trials. Read More
The FDA announced on Tuesday that it will begin removing out-of-date drug listing records from its database in one month and urged companies to update any inaccurate listings as soon as possible. Read More
The amended regulation requires patentholders to report the actual price they charge — including direct or indirect third-party discounts or rebates. Read More
The World Health Organization (WHO) has released updated guidance for quality management system (QMS) requirements for national inspectorates aimed at aligning its content to international standards, the latest QMS principles and to expanding its scope. Read More