FDA is unlikely to make permanent its rolling review, fast-track Pilot 1 program. The agency says logistics are the key reason for the program's termination.
Drug companies loved the idea of Pilot 1.
The thought of filing pieces of a new drug or biologic application one at a time and getting feedback from...
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The US FDA ended efforts to regulate lab-developed tests as medical devices for now when it did not appeal a decision from the Eastern District of Texas that tossed out the agency's final rule.
The UK regulator wants to help companies to develop bacteriophages for the treatment of infections. Its first guidance on this topic offers advice to researchers and sets out the regulatory requirements they will need to meet.
A UK research team has used artificial intelligence to find new treatments for cancer using existing US Food and Drug Administration-approved medicines that are not normally not used for the disease.
