May 28, 2024

Tedizolid – Oral, Injection products

Recognized Interpretive Criteria   Minimum InhibitoryConcentrations(mcg/mL) Disk Diffusion(zone diameter in mm)Under Review Pathogen S I R S I R Staphylococcus aureus M100 standard is recognized Enterococcus […]
May 28, 2024

OPDP Frequently Asked Questions (FAQs)

CCN Final RuleConsumer-Directed AdvertisementsDrug of ChoiceDrug Name SizeFDA-Approved Launch Information“New”Package InsertsPost-marketing ReportingPresentation of InformationPress ReleasesPre-distribution SubmissionsReminder AdvertisementsMiscellaneous Questions CCN Final Rule When does the Clear, Conspicuous and […]
May 28, 2024


On June 24, 2019, FDA issued a final guidance for industry entitled Providing Regulatory Submissions in Electronic and Non-Electronic Format–Promotional Labeling and Advertising Materials for Human […]
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