Norvir Exclusivity Is Safe; NIH Says "March-In" Test Is Availability, Not Price
Abbott has met the requirements of the Bayh/Dole Act, NIH declares. "March-in" rights are not the right way to address drug pricing, agency says: that is up to Congress.
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After almost seven years, China’s NMPA has once again published draft measures for clinical trial data protection, opening these up to public comments. While specific protection periods by drug category are proposed, some clarifications are still needed.
Plan to reorganize the agency into five offices was designed by someone who does not understand the FDA, former long-time agency official Janet Woodcock says. The proposal would eliminate highly specialized expertise in favor of “a big team of generalists,” former Principal Deputy Commissioner Joshua Sharfstein says.
Industry should be more vocal about the harms the recent reduction-in-force will have on getting drugs to market, NTEU Chapter 282 President Anthony Lee said in an interview with Pink Sheet.