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Analysis Life Sciences Thank You The 51 regulations that FDA is currently working on

Agency IQ

to provide notice and an opportunity for owners or consignees of the drug to appear before the Agency and introduce testimony prior to the destruction of their drug. The rule, will also, if finalized, address communication with State boards of pharmacy. The final rule will amend the administrative destruction provisions in 21 CFR 1.94

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Another RICOdiculous Decision

Drug & Device Law

We’ve discussed recently how a federal statute intended to allow suits against international terrorists has been misapplied as allowing suits against pharmaceutical companies. Takeda Pharmaceuticals Co. , Takeda Pharmaceutical Co. , at *6 (plaintiff “has documents and formularies reaching back to only 2009”).

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The FDA and Feasible Alternative Designs

Drug & Device Law

The court in Wolfe refused to impose a negligence duty on the defendant pharmaceutical company to develop and obtain FDA approval of the plaintiff’s non-FDA-approved alternative. In at least the short term, a popular pain reliever would have to be removed from pharmacies. were not approved by the FDA in 2009. . . .

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