jueves, 21 de diciembre de 2017

Impurity Specifications for NDAs, ANDAs, and BLAs/ Safety and Effectiveness of Health Care Antiseptics Final Rule

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Small Pharmaceutical Business and Industry

 1.  FDA is announcing the availability of MAPP 5017.2 - Establishing Impurity Specifications for NDAs, ANDAs, and BLAs Based on Clinical Relevance
This MAPP provides guiding principles and approaches for establishing drug substance and drug product impurity acceptance criteria for non-mutagenic impurities in New Drug Applications (NDAs), Abbreviated New Drug Applications (ANDAs), and Biologics License Applications (BLAs), based on the consideration of clinical relevance.  The MAPP will be effective January 18, 2018.
 2.  Safety and Effectiveness of Health Care Antiseptics; Topical Antimicrobial Drug Products for Over-the-Counter Human Use
The FDA is issuing this final rule establishing that certain active ingredients used in nonprescription antiseptic products intended for use by health care professionals in a hospital setting or other health care situations outside the hospital are not generally recognized as safe and effective. Health care antiseptic products include health care personnel hand washes, health care personnel hand rubs, surgical hand scrubs, surgical hand rubs, and patient antiseptic skin preparations (i.e., patient preoperative and pre-injection skin preparations). The FDA has deferred further rulemaking on six active ingredients used in over-the-counter (OTC) health care antiseptic products to allow for the development and submission to the record of new safety and effectiveness data for these ingredients. The deferred active ingredients are benzalkonium chloride, benzethonium chloride, chloroxylenol, alcohol (also referred to as ethanol or ethyl alcohol), isopropyl alcohol, and povidone-iodine. This rule is effective December 20, 2018.

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