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In comments to the European Medicines Agency, leading drugmakers requested more clarification, simpler language and various other revisions for the International Conference on Harmonisation’s draft addendum to its E9 guidelines. Read More
Allergan’s contested patents for the dry-eye drug Restasis took another potential hit last week as four major retailers filed an antitrust lawsuit against the drugmaker. Read More
The FDA issued an alert to clinical investigators, doctors and consumers about safety issues associated with use of Keytruda or Tecentriq as a monotherapy in oncology clinical trials. Read More
HHS Secretary Alex Azar said the administration will bring price negotiation to billions of dollars’ worth of Part B drugs administered in a physician’s office. Read More
Eli Lilly called for the agency to clarify “the requirement for a cognitive effect for approval of a drug expected to have its primary effect on function.” Read More
Only drugs meeting FDA standards for safety and efficacy — and expected to result in significant savings for consumers — would be imported on behalf of the state. Read More
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