New Initiative
Writing in the 7 August 2013 edition of the Federal Register, FDA notes that CDER is embarking on a new initiative, one prompted by its September 2000 issuance of its Good Guidance Practices (GGP) regulation. FDA explained, “The GGP regulation describes FDA policies and procedures for the development, issuance, and use of guidance documents and makes these Agency policies and procedures clear to the public. The GGP regulation provides for developing and issuing guidances that set forth initial interpretations of statutory or regulatory requirements, explain changes in interpretation of policies that are of other than minor in nature, or discuss complex scientific issues or highly controversial issues.” And, important for the purposes of its upcoming activities, the GGP regulation also directs FDA to “periodically review” its existing stockpile of guidance documents to determine whether they need minor changes, major changes, or to be withdrawn entirely due to either irrelevance or other factors.
Focus on Finalizing
As part of those minor and major changes, FDA said it wants to finalize some of the many draft guidance documents it has issued. These documents are often published with the intent of obtaining industry and public feedback, but the agency conceded that it does not always have time to finalize the documents “because of higher staff priorities.” While the documents are not referenced quite as often as final guidance documents, FDA has nevertheless referenced them in its Warning Letters to companies. For example, a May 2012 letter to a pharmaceutical company critiques the design and layout of the facility, and calls on the company to reference the best practices established in a draft guidance document, since finalized. In other words, because a guidance document only clarifies the agency’s thinking (as opposed to a regulation, which is official policy as directed by statute), a draft guidance document can carry the same weight as a final draft guidance document.
To Be Withdrawn: 23 Guidances
The Federal Register notice indicates that FDA has already identified 23 draft guidance documents in need of withdrawal. “In most cases, FDA has developed other guidances and resources to assist industry with clinical evaluation and requirements for drug approval,” the agency writes.
Those documents are:
- “Manufacturing, Processing, or Holding Active Pharmaceutical Ingredients”—issued April 1998.
- “Powder Blends and Finished Dosage Units–Stratified In-Process Dosage Unit Sampling and Assessment”—issued November 2003.
- “Forms for Registration of Producers of Drugs and Listing of Drugs in Commercial Distribution”—issued May 2001.
- “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.
- “Evaluating Clinical Studies of Antimicrobials in the Division of Anti-Infective Drug Products”—issued February 1997.
- “Empiric Therapy of Febrile Neutropenia–Developing Antimicrobial Drugs for Treatment”—issued July 1998.
- “Lyme Disease–Developing Antimicrobial Drugs for Treatment”—issued July 1998.
- “Secondary Bacterial Infections of Acute Bronchitis–Developing Antimicrobial Drugs for Treatment”—issued July 1998.
- “Streptococcal Pharyngitis and Tonsillitis–Developing Antimicrobial Drugs for Treatment”—issued July 1998.
- “Uncomplicated Gonorrhea–Developing Antimicrobial Drugs for Treatment”—issued July 1998.
- “Uncomplicated Urinary Tract Infections–Developing Antimicrobial Drugs for Treatment”—issued July 1998.
- “Vulvovaginal Candidiasis–Developing Antimicrobial Drugs for Treatment”—issued July 1998.
- “Bacterial Vaginosis–Developing Antimicrobial Drugs for Treatment”—issued July 1998.
- “Acute Bacterial Meningitis–Developing Antimicrobial Drugs for Treatment”—issued July 1998.
- “Acute or Chronic Bacterial Prostatitis–Developing Antimicrobial Drugs for Treatment”—issued July 1998.
- “Developing Antimicrobial Drugs–General Considerations for Clinical Trials”—issued July 1998.
- “Catheter-Related Bloodstream Infections–Developing Antimicrobial Drugs for Treatment”—issued October 1999.
- “Labeling Over-the-Counter (OTC) Human Drug Products—Updating Labeling in ANDAs”—issued February 2001.
- “Inhalation Drug Products Packaged in Semipermeable Container Closure Systems”—issued July 2002.
- “Listed Drugs, 30-Month Stays, and ANDAs and 505(b)(2) Applications Under HatchWaxman, as Amended by the Medicare Prescription Drug, Improvement, and Modernization Act of 2003—Questions and Answers”—issued November 2004.
- “Referencing Discontinued Labeling for Listed Drugs in Abbreviated New Drug Applications”—issued October 2000.
- “Submission of Patent Information for Certain Old Antibiotics”—issued December 2008.
- “Qualifying for Pediatric Exclusivity Under Section 505A of the Federal Food, Drug, and Cosmetic Act”—issued September 1999.
Still to Come: Revisions
In addition, FDA said it had identified a large number of guidance documents for revision and finalization, and is in the midst of “developing a plan for their completion.” Those documents are related to the following topics:
- 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;