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122. How to prepare a pre-request for designation (pre-RFD)

124. Human prescription drug and biological products: labeling for dosing based on weight or body surface area for ready-to-use containers : “dose banding” : guidance for industry

125. Hydrogen peroxide-based contact lens care products: consumer labeling recommendations : premarket notification (510(k)) submissions : guidance for industry and Food and Drug Administration staff

126. IRB waiver or alteration of informed consent for clinical investigations involving no more than minimal risk to human subjects: guidance for sponsors, investigators, and institutional review boards

127. Implementation of acceptable full-length and abbreviated donor history questionnaires and accompanying materials for use in screening donors of blood and blood components: guidance for industry

131. Institutional review board (IRB) review of individual patient expanded access submissions for investigational drugs and biological products: guidance for IRBs and clinical investigators

134. Laboratory accreditation for analyses of foods: what you need to know about the FDA regulation : guidance for industry : small entity compliance guide

135. Liposome drug products: chemistry, manufacturing, and controls : human pharmacokinetics and bioavailability : and labeling documentation

137. Logical observation identifiers names and codes for in vitro diagnostic tests: guidance for industry and Food and Drug Administration staff

139. M4 organization of the Common Technical Document for the Registration of Pharmaceuticals for Human Use