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Convenience Kits Interim Regulatory Guidance

Classification for OTC and RX Animal Drug Products

Medical Device Accessories Guidance

Application User Fees for combination products.pdf

Final Rule on UDI 9-23-2013.pdf

510(k) Format Guidance, Including Standards Form, and Extensions Clinical Trial Form and 510(k).pdf

510 K Working Group Volume II

510 K Working Group Message From Center Director

Guidance for Industry Validation of Analytical Procedures

CI FDA Course PreliminaryAgenda0809[1]

Do cGMP Reuired 3 Lots Validation

Class II Special Controls Guidance Document Antimicrobial Susceptibility Test (AST) Systems

Supplement and Changes to an Approved Applicationr

Chamges to an Approved NDA or ANDA

Test API as USP Specification

Draft Drug Starting Material GUidance

EVALUATING CLINICAL Studies of Antimicrobials in the Division of Antiinfective Drug Products

Evaluating the Safety of Antimicrobial New Animal Drugs.pdf

FOR ORIGINAL AND SUPPLEMENTAL NEW ANIMAL DRUG APPLICATIONS.pdf

FOR ORIGINAL AND SUPPLEMENTAL NEW ANIMAL DRUG APPLICATIONS.pdf

Classification for OTC and RX Animal Drug products.pdf

Extreme Weather Effect on Medical Device Safety and Quality.pdf

EU Guideline for GMP retain samples.pdf

Reserve Samples.pdf

Current Good Manufacturing Practice Requirements for Combination Products.pdf

Current Good Manufacturing Practice Requirements for Combination Products.pdf

Public Availability of Labeling CBE guidance.pdf

8-2012 DRaft guidance Refuse to accept policy for 510KUCM315014.pdf

Medical Device Classification Guidances April 11, 2013.pdf

Medical Device Classification Guidances April 11, 2013.pdf

Public Health Challenges in Influenza Diagnostics.pdf

EPA for Chlorhexidine Diacetate3038red

EPA for Chlorhexidine Diacetate3038red

EUrope Cosmetic Directive 1976

Guidance for Industry Validation of Analytical Procedures

Guidance for Industry Validation of Analytical Procedures

FY 2012 Small Business Qualification Guidance[1]

Sterile Drug Process Inspections 7356.002a

FY 2012 Small Business Qualification Guidance[1]

DRaft 11 2008 Process Validation FDA 2008 D 0559 Gdl

Process Valiadtion General Principles and Practices Draft Guidance 11-2008

Draft Process Validation General Principle and Practices 11-2008