Embed Size (px)
Citation preview
Overview of FDA 505(b)(2) Regulatory Pathway
US
CORPORATE OFFICE 400 Fifth Avenue, Suite 115, Waltham, MA 02451
781.672.4200 [email protected] globalregulatorypartners.com
FDA 505(b)(2) Regulatory Pathway
Established under the Hatch-Waxman Amendments of 1984 to the Federal Food, Drug, and Cosmetic Act, the 505(b)(2) pathway expressly permits the US Food and Drug Administration (FDA) to rely, for approval of NDAs, on data not developed by the applicant.
• Eliminate costly and time-consuming duplicative clinical studies
• Qualify for 3 or 5 years of market exclusivity
• May be eligible for orphan drug or pediatric exclusivity
• May receive an “AB” substitutability rating in the Orange Book
FDA’s finding of safety and/or effectiveness for one or more listed drugs that includes approved product labeling, and product-specific published literature.
OTC monograph establishing conditions under which the drug is GRAS/E.
Published literature that includes non-product-specific published literature.
The 505(b)(2) application should contain a full description of the chemistry, manufacturing, and controls (CMC) information.
• Drug Substance: Physical and chemical characteristics, manufacturer, method of synthesis and purification, process controls, specifications, and stability.
• Drug Product: Components, composition, specifications for each component, manufacturer, description of manufacturing and packaging procedures, in-process controls, specifications, and stability
Many 505(b)(2) applications do not require the sponsor to conduct nonclinical studies. In these cases, the successful application will contain adequate evidence of safety for the proposed product. This may include clinical data, nonclinical studies reported in the literature or approved product labeling, or other justification of why the product is safe for its proposed use.
The requirement for clinical studies will depend on various factors, including how different the proposed product is from the existing product, including indication, dosage, route of administration, and type and quality of the information available in the literature or in approved-product labeling.
What is 505(b)(2)?
What are the benefits?
PAGE 2 OF 3 JULY 2017
What type of information can an applicant rely on?
What CMC Information is required?
Are nonclinical and clinical studies required for a 505(b)(2)?
FDA 505(b)(2) Regulatory Pathway
The 505(b)(2) application should be organized in accordance with the “Common Technical Document” (CTD) format:
• MODULE 1: Mostly administrative information
• MODULE 2: Summaries of the information provided (in full) in the remaining modules. This includes a quality-related subsection called the Quality Overall Summary (QOS) and provides high level overview of critical information
• MODULE 3: Quality for drug substance(s) and drug product
• MODULE 4: Preclinical
• MODULE 5: Clinical
• Delay in approval process due to patent or exclusivity protection on the reference drug.
• Determining what additional information is needed to support the proposed change of the previously approved drug.
• Delay in availability of stability studies for new drug.
• Conducting the appropriate CMC bridging study than can show that the change in formulation doesn’t affect the safety and efficacy of the drug.
REFERENCESFederal Food Drug and Cosmetic Act—Chapter V, Section 505(b)(2) 21 USC 355(b)(2) 21 CFR 314.50 – NDAs 21 CFR 314.54 – 505(b)(2) applications 21 CFR 314. –Guidance for Industry: Applications covered by section 505(b)(2).October 1999. www.fda.gov/downloads/Drugs/Guidances/ucm079345.pdf
PAGE 3 OF 3 JULY 2017
What are the major challenges of 505(b)(2)?
CORPORATE OFFICE 400 Fifth Avenue, Suite 115, Waltham, MA 02451
781.672.4200 [email protected] globalregulatorypartners.com
What is the content of 505(b)(2) application?
