categories harmonization 
Quality Matters
JUNE 26, 2023
FDA 1 Even the requirements for TE for different types of products within individual NBCP categories may not be the same. FDA categories as complex products and/or of guidelines for development and approval of their generic versions. link] (accessed on June 12, 2023) 7 Regulatory harmonization. FDA and EMA. WHO Drug Inf.
Quality Matters
AUGUST 22, 2023
Below, we have outlined key takeaways from the FDA guidance: Harmony with EMA Overall, the FDA approach published in August is harmonized with the EMA’s July guidance on NDSRI detection and mitigation, which introduced a new Carcinogenic Potency Categorization Approach (CPCA). ng/day to 1500 ng/day.
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Quality Matters
AUGUST 23, 2023
Below, we have outlined key takeaways from the FDA guidance: Harmony with EMA Overall, the FDA approach published in August is harmonized with the EMA’s July guidance on NDSRI detection and mitigation, which introduced a new Carcinogenic Potency Categorization Approach (CPCA). ng/day to 1500 ng/day.
European Pharmaceutical Review
JULY 15, 2022
The recommendations provided to accelerate the approval of antibiotics include: Creating a specific category for antimicrobials that target serious and life-threatening infections within the regulatory framework provided for accelerated approval pathways.
The Honest Apothecary
SEPTEMBER 19, 2022
As a result, work falls under the category of – almost – a necessary evil. A balanced life is a life that harmonizes all the various parts of who I am, including whatever job or career I’ve been called to do. But my calling or career must harmonize with my other needs as well. Life Balance.
FDA Law Blog: Biosimilars
JUNE 28, 2023
Use of voluntary consensus standards can reduce regulatory burden, streamline conformity assessment, harmonize requirements globally, and enhance the quality and safety of a device. ASCA includes FDA-recognized consensus standards and related test methods across two scopes: biocompatibility and basic safety and essential performance.
Putting Patients First Blog
JANUARY 10, 2024
Risk Adjustment Models: The NHC recommends that CMS regularly reevaluate the HHS-Hierarchical Condition Category (HCC) risk score model to incorporate patient perspectives to ensure the model’s sensitivities to the complexities of complex conditions and accurately reflect health care costs and ensure financial stability for insurers.
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