Wednesday, 19 August 2020 14.00 - 15.30 h
On 7. August 2013 the US FDA published a notice in the federal register entitled "Retrospective Review of Draft Guidance Documents Issued Before 2010; Withdrawal of Guidances".
The FDA is planning to finalize a number of Guidances and is also planning to withdraw several other guidances. These activities are caused by the September 2000 final rule “Administrative Practices and Procedures; Good Guidance Practices” (GGP) (65 FR 56468; September 19, 2000). CDER has reviewed many draft guidances published before 2010. As a result of this review, FDA identified 23 draft guidances for withdrawal:
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.
23. “Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act”—issued September 1999.
In addition to identifying the first set of guidances for withdrawal, CDER also identified guidances for revision or finalization. Therefore, FDA will publish the finalized version of a number of FDA Guidances in the months to come.
In the past some companies did not consider draft guidances to be relevant. However, FDA used draft guidances to comment on inspection findings in 483 reports. Even in Warning Letters sent back in 2006 the FDA refered to draft guidances. The finalization of the drafts will send a clear message to consider these documents for internal compliance.
Source: Federal Register