Due to income that the Internal Revenue Service (IRS) says was improperly shifted to other countries, GlaxoSmithKline (GSK) allegedly owes the U.S. government $2.7 billion in unpaid taxes, the company confirmed last week.
In order for law enforcement officials to have access to older drugmaker records, the Centers for Medicare & Medicaid Services (CMS) has extended recordkeeping requirements for Medicaid-covered drugs from three years to a full decade.
The Biotechnology Industry Organization (BIO) wants the FDA to exclude promotional materials from its draft guidance on electronic submissions and develop separate guidance for advertising information that acknowledges the huge difference between ads and regulatory submissions.
If the Center for Biologics Evaluation and Research (CBER) refuses to consider a biologics manufacturer’s product application, the firm has 30 days in which to request a meeting to discuss the reasons for refusal.
Xcel Pharmaceuticals’ promotional materials for two migraine products omit risk information, make misleading comparative claims about safety and include unsubstantiated efficacy and indication claims, according to a letter from the FDA’s Division of Drug Marketing, Advertising and Communications (DDMAC).
Roche is cautioning physicians not to prescribe its popular flu treatment to patients under a year old following recent animal safety trial results, according to a letter released on the FDA’s MedWatch website late Friday.
Drug companies do not have to include stability data on undistributed reprocessed batches that are not typical of batches produced by the approved manufacturing process in annual reports to the FDA, according to the Division of Manufacturing and Product Quality (DMPQ).