FDA收回23个指南，你还在研究使用它们吗？亲

GmpForEver

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.

ptq518

楼主的信息真是及时，我想弱弱的问一句，上面的这些被FDA收回的指南现在都有对应的FDA指南来替代吗？
如果有，楼主能否也一一对应罗列一下呵呵，不一定要原文的，只要指南名称就好呵呵。

coriolan

期待新的替代指南，求高手指点

沧海.

同问。。。。

a03050183

期待对应的新指南~~~

zdlxcb

谢谢楼主分享

宁静致远1984

很有用的信息，感谢LZ分享。

琼台仙境

同问是否有更新的指南替代呢？

河西智叟

会继续研究，按着发展历程，那代表了过去。。。

江浪才尽

期待对应的新指南~~~

青城/怒云

没见到新的，老的还在研究采用，谢谢提醒。

彩虹

及时更新啊。

hongwei2000

应该是有新的指南来代替
或者是正式稿来代替Draft
比如一些关于API的现在统一用Q7A了
混合均匀性的在好像是09年出了新修订版的

快活王

你好，从哪里可以查到正轨来源，英语不太好，看FDA官网找了半天没找到。

houmeina

请问这个信息从哪里得到的，是否能够提供一个链接？

胜利者

Summary


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.