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Institutional Review Boards must comply with the Code of Federal Regulations in their written procedures but they have some flexibility with regard to the format and content, according to new HHS guidance. Read More
In an effort to curb the “gaming tactics” that delay generic drug competition, the FDA released a public list of companies found to be potentially restricting access to samples of their branded products. Read More
The FDA’s guidance on developing Alzheimer’s drugs is overly rigid when it comes to enrollment of patients in clinical trials, drugmakers said in public comments. Read More
The goal of the dashboard is to provide transparency for patients “but it could be used by a variety of individuals,” said CMS Administrator Seema Verma. Read More
The FDA took vendor IQVIA to task for a discrepancy in data regarding sales of opioid drug products that the agency said could undermine forecasts used in the fight against addiction. Read More
The Center for Medicare & Medicaid Services issued a long-awaited update to its online dashboard, increasing drug price transparency for consumers by adding year-over-year drug pricing changes and price-hiking manufacturers. “This time, you’ll actually be able to see the prices” for every drug in Medicaid and Medicare, said CMS Administrator Seema Verma at a healthcare forum hosted by The Washington Post. Read More
Clinical trial sponsors must step up their efforts to address underrepresentation of women among trial subjects, said FDA Commissioner Scott Gottlieb Wednesday during a meeting in White Oak, Maryland to commemorate National Women’s Health Week. Read More