Generic 180-Day Exclusivities Might Be Imperiled By ANDA Stability Guidance
Industry experts predict generic company pushback on some aspects of Q&A draft guidance and worry about unintended consequences, including impact on drug master files.
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In a win-win for agency and industry, generic applications submitted before deadline for new stability requirements still will be judged by old standards, even if the ANDAs are amended or resubmitted.
The agency advises sponsors to follow the stability testing recommendations in the International Conference on Harmonization guidances; three companies submit comments seeking clarification from FDA.
Proposal, which could be formally endorsed by MedPac this spring, would lower the payment rates for vaccines while simultaneously moving all preventative vaccine coverage to Medicare Part B. Commission signals further cuts to payment rate, through an average sales priced-based methodology that might eventually be recommended.