Guidance for Industry (3): 1.Hypertension Indication | 2.Non-Penicillin Beta-Lactam Risk Assessment | 3.Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products [FDA]

Guidance for Industry:

1.Hypertension Indication: Drug Labeling for Cardiovascular Outcome Claims (PDF - 147KB)

full-text:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM075072.pdf



2.Non-Penicillin Beta-Lactam Risk Assessment: A CGMP Framework (PDF - 116KB)

full-text:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM246958.pdf



3.Planning for the Effects of High Absenteeism to Ensure Availability of Medically Necessary Drug Products (PDF - 82KB)

full-text:
http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM196497.pdf