FDA REFERENCES

FDA Guidance for Quality Risk Management
Follow this link to the latest Guidance documentation from the FDA on Q9 Quality Risk Management.

FDA Guidance for Electronic Records & Electronic Signatures
Follow this link to the latest Guidance documentation from the FDA on Electronic Records and Electronic Signatures.

FDA Guidance for Providing Electronic Submissions Content of Labeling
Follow this link to the latest Guidance documentation from the FDA on Submitting Electronically for the Content of Labeling.

FDA Guidance for Providing Electronic Submissions Prescription Drug Advertising and Promotional Labeling
Follow this link to the latest Guidance documentation from the FDA on Submitting Electronically Prescription Drug Advertising and Promotional Labeling.

FDA Guidance for Labeling for Human Prescription Drugs & Biological Products
Follow this link to the latest Guidance documentation from the FDA on Labeling Implementing the New Content and Format Requirements.

Guidance PET Drugs — Current Good Manufacturing Practice (CGMP)
Follow this link to the latest Guidance documentation from the FDA on PET Drugs - cGMP.

Guidance for Industry and FDA Current Good Manufacturing Practice for Combination Products
Follow this link to the latest Guidance documentation from the FDA on cGMP for Combination Products.

FDA Guidance for Prescription Drug Marketing Act –Donation of Prescription Drug Samples to Free Clinics
Follow this link to the latest Guidance documentation from the FDA on Donating Prescription Drug Samples to Free Clinics.

Guidance for Industry E6 Good Clinical Practice: Consolidated Guidance
Follow this link to the latest Guidance documentation from the FDA on ‘E6 Good Clinical Practice”.

Guidance for Industry and Review Staff: Labeling for Human Prescription Drug and Biological Products — Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information
Follow this link to the latest Guidance documentation from the FDA on ‘Determining Established Pharmacologic Class for Use in the Highlights of Prescribing Information”.

Guidance for Industry: Drug Interaction Studies — Study Design, Data Analysis, and Implications for Dosing and Labeling: DRAFT GUIDANCE
Follow this link to the latest Guidance documentation from the FDA on ‘Drug Interaction Studies — Study Design, Data Analysis, and Implications for Dosing and Labeling: DRAFT GUIDANCE”.