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CPT Labs

How Can FDA Compliance Consultants Benefit Your Next Product Launch?

How Can FDA Compliance Consultants Benefit Your Next Product Launch? Before an OTC Drug or even a cosmetic/personal care product can be brought to market in the US, it must first undergo conceptualization, development and a rigorous testing process to ensure that it meets FDA requirements for safety (cosmetic/personal care

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stability testing
OTC Pharmaceuticals
William J. Neumann

Stability Testing Requirements For OTC & Drug Products in the USA

All over-the-counter (OTC) and prescription (Rx) drug products distributed within the USA are required to display an expiration date that is supported by stability studies that have been conducted in accordance with the current FDA and ICH Guidelines. Each strength of a drug product, and each primary package and closure

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Neo-Synalar Modified 48 Hour Patch Test

A 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base), fluocinolone acetonide 0.025%) Cream . Subjects also receive a positive control (Sodium Lauryl Sulfate) and a negative control (Saline). The primary objective of this study was to determine

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Neo-Synalar Modified 48 Hour Patch Test

A 48 hour patch test performed in healthy volunteers to determine the presensitization (pre-existing allergy) of Neo-Synalar (neomycin sulfate 0.5%(0.35% neomycin base), fluocinolone acetonide 0.025%)

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