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the review of draft guidance documents issued before 2010 to determine their
status, and to decide whether those guidances should be withdrawn, revised, or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