确认撤销的指南草案涉及主题
• Current good manufacturing practice (cGMP) compliance specific to manufacturing, processing, and dose unit sampling and assessment;
• Development of antimicrobial drugs for the treatment of acute bronchitis, bacterial meningitis, bacterial prostatitis, bacterial vaginosis, catheter- related bloodstream infections, febrile neutropenia, gonorrhea, Lyme disease, streptococcal pharyngitis and tonsillitis, uncomplicated urinary tract infections, and vuvlovaginal candidiasis;
• Clinical trials for developing antimicrobial drugs and packaging of inhalation products in semipermeable container systems;
• Approval of abbreviated new drug applications (ANDAs) and 505(b)(2) applications under the Drug Price Competition and Patent Term Restoration Act of 1984 (i.e., the Hatch- Waxman Act);
• Procedures relating to submission of patent information, submission of marketing applications, and forms for registration and disclosure of information;
• Labeling in ANDAs; and
• Qualifying for pediatric exclusivity under the Best Pharmaceuticals for Children Act.
具体为
1. Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients—issued April 1998.
2. Powder Blends and Finished Dosage Units—Stratified In-Process Dosage Unit Sampling and Assessment— issued November 2003.
3. Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution—issued May 2001.
4. Disclosing Information Provided to Advisory Committees in Connection With Open Advisory Committee Meetings Related to the Testing or Approval of New Drugs and Convened by CDER, Beginning on January 1, 2000—issued December 1999.
5. Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products— issued February 1997.
6. Empiric Therapy of Febrile Neutropenia—Developing Antimicrobial Drugs for Treatment— issued July 1998.
7. Lyme Disease—Developing Antimicrobial Drugs for Treatment— issued July 1998.
8. Secondary Bacterial Infections of Acute Bronchitis—Developing Antimicrobial Drugs for Treatment— issued July 1998.
9. Streptococcal Pharyngitis and Tonsillitis—Developing Antimicrobial Drugs for Treatment—issued July 1998.
10. Uncomplicated Gonorrhea— Developing Antimicrobial Drugs for Treatment—issued July 1998.
11. Uncomplicated Urinary Tract Infections—Developing Antimicrobial Drugs for Treatment—issued July 1998.
12. Vulvovaginal Candidiasis— Developing Antimicrobial Drugs for Treatment—issued July 1998.
13. Bacterial Vaginosis—Developing Antimicrobial Drugs for Treatment— issued July 1998.
14. Acute Bacterial Meningitis— Developing Antimicrobial Drugs for Treatment—issued July 1998.
15. Acute or Chronic Bacterial Prostatitis—Developing Antimicrobial Drugs for Treatment—issued July 1998.
16. Developing Antimicrobial Drugs— General Considerations for Clinical Trials—issued July 1998.
17. Catheter-Related Bloodstream Infections—Developing Antimicrobial Drugs for Treatment—issued October 1999.
18. Labeling Over-the-Counter (OTC) Human Drug Products—Updating Labeling in ANDAs—issued February 2001.
19. Inhalation Drug Products Packaged in Semipermeable Container Closure Systems—issued July 2002.
20. Listed Drugs, 30-Month Stays, and ANDAs and 505(b)(2) Applications Under Hatch-Waxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—Questions and Answers— issued November 2004.
21. Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications—issued October 2000.
22. Submission of Patent Information for Certain Old Antibiotics—issued December 2008. For information on the preceding four guidances (number 19 through 22), contact the Office of Pharmaceutical Science in CDER. 23. Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act— issued September 1999.
（1-4 contact the Office of Compliance in CDER, 5-17 contact the Office of Antimicrobial Products in the Office of New Drugs in CDER, 18 contact the Office of Drug Evaluation IV in the Office of New Drugs in CDER, 19-23 contact the Pediatric and Maternal Health Staff in the Office of New Drugs in CDER）
考虑修改后形成终稿的指南主题包括
• Biopharmaceutics;
• Chemistry, manufacturing, and controls;
• Clinical pharmacology;
• Combination products;
• cGMP compliance;
• Development of antimicrobial drugs;
• Drug advertisements;
• Drug safety;
• Electronic submissions;
• Labeling;
• OTC products;
• Pharmacology and toxicology;
• Procedural guidances; and
• Radiopharmaceuticals.
The Food and Drug Administration (FDA) is announcing an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010 to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes. Guidances that are no longer up to date, and for which more current information is available, will be withdrawn. Guidances that reflect CDER's current thinking, CDER will decide whether to revise or finalize. This notice describes CDER's initiative, announces the first group of guidances to be withdrawn, describes in general terms draft guidances under consideration for revision or finalization, and explains how CDER is making this process as transparent as possible.
in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010 to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor