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Final Version 1.4Associated Guidance Document(s):Draft Guidance for In
Final Version 1.4Associated Guidance Document(s):Draft Guidance for In
celsa-spraggs
Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submission
Guidance for Industry Fulfilling Regulatory Requirements for Postmarketing Submission
tatyana-admore
Document Management Nomenclature
Document Management Nomenclature
alexa-scheidler
DRAFT GUIDANCEThis guidance document is Submit comments on this draft
DRAFT GUIDANCEThis guidance document is Submit comments on this draft
faustina-dinatale
Guidance for Industry How to Comply with the Pediatric Research Equity Act DRAFT GUIDANCE
Guidance for Industry How to Comply with the Pediatric Research Equity Act DRAFT GUIDANCE
trish-goza
Guidance for Industry Developing Products for Weight Management DRAFT GUIDANCE This guidance
Guidance for Industry Developing Products for Weight Management DRAFT GUIDANCE This guidance
stefany-barnette
Guidance for Industry and FDA Staff Submissions for Postapproval Modifications to a Combination
Guidance for Industry and FDA Staff Submissions for Postapproval Modifications to a Combination
test
Guidance for Industry Complicated Intra Abdominal Infections Developing Drugs for Treatment
Guidance for Industry Complicated Intra Abdominal Infections Developing Drugs for Treatment
kittie-lecroy
Guidance for Industry Expanded Access to Investigational Drugs for Treatment Use Qs
Guidance for Industry Expanded Access to Investigational Drugs for Treatment Use Qs
pamella-moone
Guidance for Industry Contract Manufacturing Arrangements for Drugs Quality Agreements
Guidance for Industry Contract Manufacturing Arrangements for Drugs Quality Agreements
tawny-fly
Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE
Guidance for Industry ANDA Submissions Prior Approval Supplements Under GDUFA DRAFT GUIDANCE
conchita-marotz
Informed Consent Information Sheet Guidance for IRBs Clinical Investigators and Sponsors
Informed Consent Information Sheet Guidance for IRBs Clinical Investigators and Sponsors
cheryl-pisano
Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New
Guidance for Industry Distributing Scientific and Medical Publications on Unapproved New
calandra-battersby
Guidance for Industry Considerations for the Design of Early Phase Clinical Trials of
Guidance for Industry Considerations for the Design of Early Phase Clinical Trials of
briana-ranney
ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits
ANDA Submissions Refuse to Receive for Lack of Proper Justification of Impurity Limits
pasty-toler
Guidance for Industry Safety Considerations for Container Labels and Carton Labeling
Guidance for Industry Safety Considerations for Container Labels and Carton Labeling
liane-varnes
Guidance for Industry Concerns Related to the use of Clove Oil as an Anesthetic for Fish
Guidance for Industry Concerns Related to the use of Clove Oil as an Anesthetic for Fish
lindy-dunigan
CBS-16 Documents Types of document
CBS-16 Documents Types of document
cheryl-pisano
Guidance for Industry Naming of Drug Products Containing Salt Drug Substances DRAFT GUIDANCE
Guidance for Industry Naming of Drug Products Containing Salt Drug Substances DRAFT GUIDANCE
karlyn-bohler
Guidance for Industry DirecttoConsumer Television Advertisements FDAAA DTC Television
Guidance for Industry DirecttoConsumer Television Advertisements FDAAA DTC Television
stefany-barnette
Guidance for Industry DirecttoConsumer Television Advertisements FDAAA DTC Television
Guidance for Industry DirecttoConsumer Television Advertisements FDAAA DTC Television
liane-varnes
Unified Approach to Stormwater Monitoring in Southern California
Unified Approach to Stormwater Monitoring in Southern California
tawny-fly
How to Comply with the Pediatric DRAFT GUIDANCE This guidance document
How to Comply with the Pediatric DRAFT GUIDANCE This guidance document
celsa-spraggs
Guidance for Industry Interim Product Reporting for Human Drug Compounding Outsourcing
Guidance for Industry Interim Product Reporting for Human Drug Compounding Outsourcing
giovanna-bartolotta