FDA Sends Info on IVD Device Studies to OMB
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Newer Approach Could Help Biosimilar Development: FDA
FDA researchers say there have been global efforts to streamline biosimilar development of therapeutic proteins (TPs) by reducing reliance on comparative efficacy studies and moving instead toward a comparative analytic assessment plus pharmacokinetics approach. Writing in the open-source Clinical Pharmacology & Therapeutics, the researchers say the new approach is
Revised Drug Inspection Framework Critiqued by Attorneys
FDA's updated operating framework for drug facility inspections makes several procedural changes affecting inspection classifications, remote assessments and the use of foreign regulatory inspection reports, according to an analysis by Hogan Lovells. The revised Concept of Operations (ConOps 2.0) replaces the agency's 2017 framework governing
USV Private Limited CGMP Violations
A 4/7-4/17 FDA inspection at the USV Private Limited drug manufacturing facility in Dabhel, Daman, Dadra and Nagar Haveli and Dam, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. An 11/2 Warning Letter says the specific violations were: · failure to
Bio Plan to Maintain U.S. Biotechnology Lead
BIO says the window to protect America’s biotechnology lead is closing and it offers a seven-step plan to ensure the U.S. remains the global biotech leader for decades to come. In a white paper, “Bio Advance: Securing America’s Biotech Century,” the trade association says the biotechnology