Thursday, 29 August 2013

FDA Guidance Update

According to the Federal Register, the Food and Drug Administration (FDA) has annoucned an initiative in the Center for Drug Evaluation and Research (CDER) involving the review of draft guidance documents issued before 2010 to determine their status, and to decide whether those guidances should be withdrawn, revised, or finalized with only minor changes.

CDER is withdrawing the following guidances:

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.

For information on the four preceding guidances, contact the Office of Compliance in CDER.

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.

For information on the preceding 13 guidances (number 5 through 17), contact the Office of Antimicrobial Products in the Office of New Drugs in CDER.

18. “Labeling Over-the-Counter (OTC) Human Drug Products—Updating Labeling in ANDAs”—issued February 2001.

For information on the preceding guidance (number 18), contact the Office of Drug Evaluation IV in the Office of New Drugs in CDER.

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.
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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.

Posted by Tim Sandle