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Some drugmakers refuse to sell samples of products using REMS with Elements to Assure Safe Use (ETASU), affecting distribution to generic competitors, or set conditions for sales that generics companies cannot meet. Read More
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