Ill STAT. 2296 PUBLIC LAW 105-115—NOV. 21, 1997 Public Law 105-115 105th Congress An Act N 21 1QQ7 "^^ amend the Federal Food, Drug, and Cosmetic Act and the Public Health Service
Act to improve the regulation of food, drugs, devices, and biological products, [8. 830] and for other purposes. Be it enacted by the Senate and House of Representatives of Food and Drug the United States of America in Congress assembled. Administration Modernization SECTION 1. SHORT TITLE; REFERENCES; TABLE OF CONTENTS. 2l\jSC?0^i note ^^^ SHORT TITLE.— This Act may be cited as the "Food and Drug Administration Modernization Act of 1997". (b) REFERENCES.— Except as otherwise specified, whenever in this Act an amendment or repeal is expressed in terms of an amendment to or a repeal of a section or other provision, the reference shall be considered to be made to that section or other provision of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 301 et seq.). (c) TABLE OF CONTENTS.— The table of contents for this Act is as follows: Sec. 1. Short title; references; table of contents. Sec. 2. Definitions. TITLE I—IMPROVING REGULATION OF DRUGS Subtitle A—Fees Relating to Drugs Sec. 101. Findings. Sec. 102. Definitions. Sec. 103. Authority to assess and use drug fees. Sec. 104. Annual reports. Sec. 105. Savings. Sec. 106. Effective date. Sec. 107. Termination of effectiveness. Subtitle B—Other Improvements Sec. 111. Pediatric studies of drugs. Sec. 112. Expediting study and approval of fast track drugs. Sec. 113. Information program on clinical trials for serious or life-threatening diseases. Sec. 114. Health care economic information. Sec. 115. Clinical investigations. Sec. 116. Manufacturing changes for drugs. Sec. 117. Streamlining clinical research on drugs. Sec. 118. Data requirements for drugs and biologies. Sec. 119. Content and review of applications. Sec. 120. Scientific advisory panels. Sec. 121. Positron emission tomography. Sec. 122. Requirements for radiopharmaceuticals. Sec. 123. Modernization of regulation. Sec. 124. Pilot and small scale manufacture. Sec. 125. Insulin and antibiotics. Sec. 126. Elimination of certain labeling requirements. Sec. 127. Application of Federal law to practice of pharmacy compounding.