Description
Changing or unclear interpretations of clinical trail data needed to demonstrate the effectiveness and safety of anitmicrobial drug products have at times lead to confusion and frustration on the part of both applicants and Division of Anti-Infective Drug Products reviewers.
Scope & Applicability
Product Classes
2demonstrate the effectiveness and safety of antimicrobial drug products; Products that kill or inhibit the growth of microorganisms
The category of drugs being discussed regarding labeling and promotion.; establishment of effectiveness and risk-to-benefit profile for marketing application; Drug product being evaluated for effectiveness in infections; drug products for treating various infections; Product class discussed for clinical development
Stakeholders
5Entities submitting supplements to BLAs
facilitate discussions between a prospective subject and an investigator; Responsible for conducting research and providing informed consent
responsible for justifying omission of studies
Intended audience for the pharmaceutical development section
Entity submitting development data and knowledge; Entity performing the work process for change
Regulatory Context
Attributes
10Demonstration that pre- and postchange products are equivalent
provide the requisite information for approval of a range of doses... that encompass an appropriate benefit-to-risk ratio
selected to try to demonstrate the shape of the dose-response curve
specific labeling restriction for products failing to eradicate major pathogens
labeling status for products not for first line therapy
Clinical and radiographic endpoints in pneumonia trials
factor in determining consistency with drug labeling
comparing the direction of the independent 95% confidence intervals testing
primary effectiveness parameter in UTI studies
must be established for antimicrobial drug product marketing application
Related CFR Sections (5)
- 21CFR314.106§ 314.106 Foreign data.
(a) General. The acceptance of foreign data in an application generally is governed by § 312.120 of this chapter .Read full regulation →
- 21CFR312.120§ 312.120 Foreign clinical studies not conducted under an IND.
(a) Acceptance of studies.Read full regulation →
- 21CFR201.57§ 201.57 Specific requirements on content and format of labeling for human prescription drug and biological products described in § 201.56(b)(1) .
The requirements in this section apply only to prescription drug products described in § 201.56(b)(1) and must be implemented according to the schedule specified in § 201.56(c) , except for the requirement in paragraph (c)(18) of this section to reprint any FDA-approved patient labeling at the end oRead full regulation →
- 21CFR201.58§ 201.58 Waiver of labeling requirements.
An applicant may ask the Food and Drug Administration to waive any requirement under §§ 201.56 , 201.57 , and 201.80 . A waiver request must be submitted in writing to the Director (or the Director's designee), Center for Drug Evaluation and Research, Food and Drug Administration, Central Document RRead full regulation →
- 21CFR314.126§ 314.126 Adequate and well-controlled studies.
(a) The purpose of conducting clinical investigations of a drug is to distinguish the effect of a drug from other influences, such as spontaneous change in the course of the disease, placebo effect, or biased observation. The characteristics described in paragraph (b) of this section have been develRead full regulation →
See Also (8)
- Upper Facial Lines: Developing Botulinum Toxin Drug Products (Status: Draft)
- Frequently Asked Questions – Statement of Investigator (Form FDA 1572): Guidance for Sponsors, Clinical Investigators, and IRBs (Status: Final)
- FDA Acceptance of Foreign Clinical Studies Not Conducted Under an IND: Frequently Asked Questions: Guidance for Industry and FDA Staff (Status: Final)
- Neglected Tropical Diseases of the Developing World: Developing Drugs for Treatment or Prevention (Status: Final)
- Use of Electronic Health Record Data in Clinical Investigations Guidance for Industry (Status: Final)
- Chronic Hepatitis D Virus Infection: Developing Drugs for Treatment Guidance for Industry (Status: Draft)
- Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment (Status: Final)
- Postmarketing Approaches to Obtain Data on Populations Underrepresented in Clinical Trials for Drugs and Biological Products (Status: Draft)