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Press Secretary Sarah Sanders said the White House could not provide further details, “but we do expect some specific policy pieces to come out on that soon.” Read More
FDA Commissioner Scott Gottlieb said the agency may ask Congress for more authority to deal with intravenous drug shortages but he also called for voluntarily collaboration by the industry. Read More
In the latest development over alleged misconduct by Insys in promoting its fentanyl-based opioid Subsys, a former sales representative admitted to participating in a scheme to bribe doctors to prescribe the drug under the pretext of paying speaking fees. Read More
The FDA called out brand drugmakers for using REMS to delay and block competitive generic drugs, announcing two draft guidances designed to help generic drug makers get their products to market and preserve the safety controls intended by REMS. Read More
Post-approval change management protocols submitted and approved after approval of the original application should be accompanied by an updated product lifecycle management document. Read More
The FDA released the ICH’s Q12 draft guidance on pharmaceutical product lifecycle management (PLCM) for post-approval changes in chemistry, manufacturing and controls. Read More
The FDA recommended systemic characterization of a drug’s effect on blood pressure during drug development in newly issued guidance, which addresses precision of blood pressure measurements in assessing the effects of short-term and chronic use drugs in development. Read More
A lower court’s dismissal of a whistleblower lawsuit against Otsuka and Bristol Myers-Squibb will stand, as the U.S. Supreme Court this week declined to hear the case. Read More