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FDA Title 21 CFR Parts |
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ICH Titles |
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EU & Canadian Titles |
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1 - General enforcement regulations |
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ICH
Q1A (R2) - Stability Testing of New Drug Substances and
Products |
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2 - General administrative rulings and decisions |
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Q1B Stability
Testing : - Photostability
Testing of New Drug Substances and Products |
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3 - Product jurisdiction |
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Q1C
- Stability
Testing for New Dosage Forms |
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5 - Organization |
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Q1D
- Bracketing and
Matrixing Designs for Stability Testing of New Drug
Substances and Products |
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7 - Enforcement policy |
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ICH Q1E
- Evaluation of
Stability Data |
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10 - Administrative practices and procedures |
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Q1F Stability Data Package for Registration Applications in
Climatic Zones III and IV |
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11 - Electronic records; electronic signatures |
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Q2(R1) New title: Validation of Analytical Procedures: Text
and Methodology
Previously: Text on Validation of Analytical Procedures |
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11+ - 11
with Preambles |
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Q2A
Validation of Analytical Procedures: Methodology (in Q2(R1))
Q2B |
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11+ - 11
Spanish |
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Q3A(R2) Impurities in New Drug Substances
Q3A(R) |
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12 - Formal evidentiary public hearing |
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Q3B(R2) Impurities in New Drug Products
Q3B(R) |
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13 - Public hearing before a public board of inquiry |
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14 - Public hearing before a public advisory committee |
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15 - Public hearing before the Commissioner |
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16 - Regulatory hearing before the Food and Drug
Administration |
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17 - Civil money penalties hearings |
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19 - Standards of conduct and conflicts of interest |
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20 - Public information |
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21 - Protection of privacy |
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25 - Environmental impact considerations |
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26 - Mutual recognition of pharmaceutical good manufacturing
practice reports, medical device quality system audit
reports, and certain medical device product evaluation
reports: United States and The European Community |
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50 - Protection of human subjects |
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ICH Q2B
- |
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54 - Financial disclosure by clinical investigators |
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ICH Q5E
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56 - Institutional Review Boards |
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ICH Q7A
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58 - Good laboratory practice for nonclinical laboratory
studies |
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ICH Q8
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60 - Patent term restoration |
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ICH Q9
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70 - Color additives |
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ICH E2A
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71 - Color additive petitions |
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ICH E2B
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73 - Listing of color additives exempt from certification |
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ICH E4
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74 - Listing of color additives subject to certification |
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ICH E8
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80 - Color additive certification |
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ICH S2A
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81 - General specifications and general restrictions for
provisional color additives for use in foods, drugs, and
cosmetics |
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ICH S6
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82 - Listing of certified provisionally listed colors and
specifications |
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ICH S7
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99 - Dissemination of information on unapproved/new uses for
marketed drugs, biologics, and devices |
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100 - General |
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101 - Food labeling |
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102 - Common or usual name for nonstandardized foods |
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104 - Nutritional quality guidelines for foods |
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105 - Foods for special dietary use |
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106 - Infant formula quality control procedures |
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107 - Infant formula |
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108 - Emergency permit control |
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109 - Unavoidable contaminants in food for human consumption and
food-packaging material |
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110 - Current good manufacturing practice in manufacturing,
packing, or holding human food |
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110+ - 110
Spanish |
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111 - 111 Good Manufacturing Practices for Dietary
Supplement |
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113 - Thermally processed low-acid foods packaged in
hermetically sealed containers |
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114 - Acidified foods |
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115 - Shell eggs |
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119 - Dietary supplements that present a significant or
unreasonable risk |
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120 - Hazard Analysis and Critical Control Point (HACCP)
systems |
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123 - Fish and fishery products |
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129 - Processing and bottling of bottled drinking water |
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130 - Food standards: General |
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131 - Milk and cream |
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133 - Cheeses and related cheese products |
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135 - Frozen desserts |
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136 - Bakery products |
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137 - Cereal flours and related products |
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139 - Macaroni and noodle products |
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145 - Canned fruits |
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146 - Canned fruit juices |
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150 - Fruit butters, jellies, preserves, and related products |
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152 - Fruit pies |
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155 - Canned vegetables |
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156 - Vegetable juices |
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158 - Frozen vegetables |
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160 - Eggs and egg products |
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161 - Fish and shellfish |
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163 - Cacao products |
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164 - Tree nut and peanut products |
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165 - Beverages |
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166 - Margarine |
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168 - Sweeteners and table syrups |
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169 - Food dressings and flavorings |
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170 - Food additives |
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171 - Food additive petitions |
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172 - Food additives permitted for direct addition to food for
human consumption |
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173 - Secondary direct food additives permitted in food for
human consumption |
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174 - Indirect food additives: General |
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175 - Indirect food additives: Adhesives and components of
coatings |
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176 - Indirect food additives: Paper and paperboard components |
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177 - Indirect food additives: Polymers |
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178 - Indirect food additives: Adjuvants, production aids, and
sanitizers |
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179 - Irradiation in the production, processing and handling of
food |
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180 - Food additives permitted in food or in contact with food
on an interim basis pending additional study |
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181 - Prior-sanctioned food ingredients |
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182 - Substances generally recognized as safe |
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184 - Direct food substances affirmed as generally recognized as
safe |
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186 - Indirect food substances affirmed as generally recognized
as safe |
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189 - Substances prohibited from use in human food |
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190 - Dietary supplements |
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200 - General |
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201 - Labeling |
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202 - Prescription drug advertising |
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203 - Prescription drug marketing |
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205 - Guidelines for State licensing of wholesale prescription
drug distributors |
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206 - Imprinting of solid oral dosage form drug products for
human use |
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207 - Registration of producers of drugs and listing of drugs in
commercial distribution |
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208 - Medication Guides for prescription drug products |
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210/211 - Current good manufacturing practice in manufacturing,
processing, packing, or holding of drugs; general
Current good manufacturing practice for finished
pharmaceuticals |
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210/211 -
210/211 Spanish |
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210/211 -
210/211 with Keyword Index |
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210/211 -
210/211 with Preambles |
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216 - Pharmacy compounding |
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225 - Current good manufacturing practice for medicated feeds |
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226 - Current good manufacturing practice for Type A medicated
articles |
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250 - Special requirements for specific human drugs |
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290 - Controlled drugs |
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299 - Drugs; official names and established names |
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300 - General |
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310 - New drugs |
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312 - Investigational new drug application |
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314 - Applications for FDA approval to market a new drug |
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315 - Diagnostic radiopharmaceuticals |
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316 - Orphan drugs |
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320 - Bioavailability and bioequivalence requirements |
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328 - Over-the-counter drug products intended for oral ingestion
that contain alcohol |
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330 - Over-the-counter (OTC) human drugs which are generally
recognized as safe and effective and not misbranded |
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331 - Antacid products for over-the-counter (OTC) human use |
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332 - Antiflatulent products for over-the-counter human use |
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333 - Topical antimicrobial drug products for over-the-counter
human use |
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335 - Antidiarrheal drug products for over-the-counter human
use |
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336 - Antiemetic drug products for over-the-counter human use |
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338 - Nighttime sleep-aid drug products for over-the-counter
human use |
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340 - Stimulant drug products for over-the-counter human use |
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341 - Cold, cough, allergy, bronchodilator, and antiasthmatic
drug products for over-the-counter human use |
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343 - Internal analgesic, antipyretic, and antirheumatic drug
products for over-the-counter human use |
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344 - Topical OTIC drug products for over-the-counter human
use |
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346 - Anorectal drug products for over-the-counter human use |
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347 - Skin protectant drug products for over-the-counter human
use |
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348 - External analgesic drug products for over-the-counter
human use |
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349 - Ophthalmic drug products for over-the-counter human use |
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350 - Antiperspirant drug products for over-the-counter human
use |
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352 - Sunscreen drug products for over-the-counter human use
[stayed indefinitely] |
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355 - Anticaries drug products for over-the-counter human use |
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357 - Miscellaneous internal drug products for over-the-counter
human use |
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358 - Miscellaneous external drug products for over-the-counter
human use |
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361 - Prescription drugs for human use generally recognized as
safe and effective and not misbranded: Drugs used in
research |
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369 - Interpretative statements re warnings on drugs and devices
for over-the-counter sale |
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500 - General |
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501 - Animal food labeling |
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502 - Common or usual names for nonstandardized animal foods |
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509 - Unavoidable contaminants in animal food and food-packaging
material |
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510 - New animal drugs |
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511 - New animal drugs for investigational use |
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514 - New animal drug applications |
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515 - Medicated feed mill license |
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520 - Oral dosage form new animal drugs |
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522 - Implantation or injectable dosage form new animal drugs |
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524 - Ophthalmic and topical dosage form new animal drugs |
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526 - Intramammary dosage forms |
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529 - Certain other dosage form new animal drugs |
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530 - Extralabel drug use in animals |
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556 - Tolerances for residues of new animal drugs in food |
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558 - New animal drugs for use in animal feeds |
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564 - [Reserved] |
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570 - Food additives |
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571 - Food additive petitions |
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