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151
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Guidance for industry [electronic resource] : IND exemptions for studies of lawfully marketed drug o
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Axe Federal Documents Online:Available
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2004
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152
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Guidance for industry [electronic resource] : IND meetings for human drugs and biologics, chemistry,
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Axe Federal Documents Online:Available
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2001
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153
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Guidance for industry [electronic resource] : independent consultants for biotechnology clinical tri
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Axe Federal Documents Online:Available
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2004
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154
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Guidance for industry [electronic resource] : indexing structured product labeling.
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Axe Federal Documents Online:Available
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2008
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155
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Guidance for industry [electronic resource] : INDs for phase 2 and phase 3 studies, chemistry, manuf
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Axe Federal Documents Online:Available
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2003
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156
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Guidance for industry [electronic resource] : information program on clinical trials for serious or
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Axe Federal Documents Online:Available
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2002
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157
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Guidance for industry [electronic resource] : information request and discipline review letters unde
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Axe Federal Documents Online:Available
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2001
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158
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Guidance for industry [electronic resource] : informed consent recommendations for source plasma don
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Axe Federal Documents Online:Available
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2007
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159
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Guidance for industry [electronic resource] : integrated summaries of effectiveness and safety : loc
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Axe Federal Documents Online:Available
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2009
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160
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Guidance for industry [electronic resource] : integrated summary of effectiveness.
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Axe Federal Documents Online:Available
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2008
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161
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Guidance for industry [electronic resource] : interpreting sameness of monoclonal antibody products
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Axe Federal Documents Online:Available
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1999
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162
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Guidance for industry [electronic resource] : investigating out-of-specification test results (OOS)
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Axe Federal Documents Online:Available
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2006
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163
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Guidance for industry [electronic resource] : labeling guidance for OTC topical drug products for th
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Axe Federal Documents Online:Available
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1998
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164
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Guidance for industry [electronic resource] : "lookback" for hepatitis c virus (HCV) : produ
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Axe Federal Documents Online:Available
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2007
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165
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Guidance for industry [electronic resource] : M2 eCTD : electronic common technical document specifi
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Axe Federal Documents Online:Available
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2003
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166
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Guidance for industry [electronic resource] : M2, eCTD specification, questions & answers and change
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Axe Federal Documents Online:Available
|
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2005
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167
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Guidance for industry [electronic resource] : M3 nonclinical safety studies for the conduct of human
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Axe Federal Documents Online:Available
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1997
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168
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Guidance for industry [electronic resource] : M4, organization of the CTD.
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Axe Federal Documents Online:Available
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2001
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169
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Guidance for industry [electronic resource] : M4, the CTD, efficacy questions and answers.
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Axe Federal Documents Online:Available
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2004
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170
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Guidance for industry [electronic resource] : M4, the CTD, general questions and answers.
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Axe Federal Documents Online:Available
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2004
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171
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Guidance for industry [electronic resource] : M4E, the CTD, efficacy.
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Axe Federal Documents Online:Available
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2001
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172
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Guidance for industry [electronic resource] : M4Q, the CTD, quality.
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Axe Federal Documents Online:Available
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2001
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173
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Guidance for industry [electronic resource] : M4S, the CTD, safety.
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Axe Federal Documents Online:Available
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2001
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174
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Guidance for industry [electronic resource] : M4S, the CTD, safety appendices.
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Axe Federal Documents Online:Available
|
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2001
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175
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Guidance for industry [electronic resource] : major, minor, and telephone amendments to abbreviated
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Axe Federal Documents Online:Available
|
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2001
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176
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Guidance for industry [electronic resource] : manufacturing biological intermediates and biological
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Axe Federal Documents Online:Available
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2007
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177
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Guidance for industry [electronic resource] : manufacturing, processing, or holding active pharmaceu
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Axe Federal Documents Online:Available
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1998
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178
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Guidance for industry [electronic resource] : MedWatch form FDA 3550A, mandatory reporting of advers
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Axe Federal Documents Online:Available
|
|
2005
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179
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Guidance for industry [electronic resource] : metered dose inhaler (MDI) and dry powder inhaler (DPI
|
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Axe Federal Documents Online:Available
|
|
1998
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180
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Guidance for industry [electronic resource] : minimally manipulated, unrelated, allogeneic placental
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Axe Federal Documents Online:Available
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2006
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181
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Guidance for industry [electronic resource] : monoclonal antibodies used as reagents in drug manufac
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Axe Federal Documents Online:Available
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2001
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182
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Guidance for industry [electronic resource] : nasal spray and inhalation solution, suspension, and s
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Axe Federal Documents Online:Available
|
|
2002
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183
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Guidance for industry [electronic resource] : national uniformity for nonprescription drugs : ingred
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Axe Federal Documents Online:Available
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|
1998
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|
184
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Guidance for industry [electronic resource] : NDA's : impurities in drug substances.
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|
Axe Federal Documents Online:Available
|
|
2000
|
|
185
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Guidance for industry [electronic resource] : new contrast imaging indication considerations for dev
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Axe Federal Documents Online:Available
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2008
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186
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Guidance for industry [electronic resource] : nonclinical safety evaluation of drug or biologic comb
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Axe Federal Documents Online:Available
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2006
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187
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Guidance for industry [electronic resource] : nonclinical safety evaluation of pediatric drug produc
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Axe Federal Documents Online:Available
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2006
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188
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Guidance for industry [electronic resource] : nonclinical studies for the safety evaluation of pharm
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Axe Federal Documents Online:Available
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2005
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189
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Guidance for industry [electronic resource] : nonsterile semisolid dosage forms : scale-up and posta
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Axe Federal Documents Online:Available
|
|
1997
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190
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Guidance for industry [electronic resource] : notifying FDA of fatalities related to blood collectio
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Axe Federal Documents Online:Available
|
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2003
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191
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Guidance for industry [electronic resource] : nucleic acid testing (NAT) for human immunodeficiency
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Axe Federal Documents Online:Available
|
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2005
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192
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Guidance for industry [electronic resource] : nucleic acid testing (NAT) to reduce the possible risk
|
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|
Axe Federal Documents Online:Available
|
|
2008
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193
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Guidance for industry [electronic resource] : orally disintegrating tablets.
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Axe Federal Documents Online:Available
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2008
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194
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Guidance for industry [electronic resource] : PAC-ATLS : postapproval changes, analytical testing l
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Axe Federal Documents Online:Available
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1998
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195
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Guidance for industry [electronic resource] : part 11, electronic records : electronic signatures--s
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Axe Federal Documents Online:Available
|
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2003
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196
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Guidance for industry [electronic resource] : PAT, a framework for innovative pharmaceutical develop
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Axe Federal Documents Online:Available
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2004
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197
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Guidance for industry [electronic resource] : patient-reported outcome measures, use in medical prod
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Axe Federal Documents Online:Available
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2006
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198
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Guidance for industry [electronic resource] : pharmaceutical components at risk for melamine contami
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Axe Federal Documents Online:Available
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|
2009
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199
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Guidance for industry [electronic resource] : pharmacogenomic data submissions.
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Axe Federal Documents Online:Available
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2005
|
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200
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Guidance for industry [electronic resource] : pharmacogenomic data submissions, companion evidence.
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|
Axe Federal Documents Online:Available
|
|
2007
|
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