Monday, February 11, 2013

ICH Photosafety - FDA EU Draft Guidance

ICH Photosafety Guidance Aims to Bridge FDA, EU Differences:

"The FDA and Health Canada recently opened for industry comment new guidance from the International Conference on Harmonisation  on the photosafety testing of drug compounds.

“The S10 draft guidance document clarifies some points in the current EMA and FDA guidance that are known weaknesses, based on accumulated information and experience since those documents were issued in the mid-2000s,” Doug Learn, director of photobiology at Charles River, told In-Pharmatechnologist.com."

'via Blog this'

Read the draft guidance:
INTERNATIONAL CONFERENCE ON HARMONISATION OF TECHNICAL REQUIREMENTS FOR REGISTRATION OF PHARMACEUTICALS FOR HUMAN USE - DRAFT CONSENSUS GUIDELINE - PHOTOSAFETY EVALUATION OF PHARMACEUTICALS - S10 (pdf)

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