miércoles, 28 de diciembre de 2016

FDA seeks input on product-specific guidances to facilitate generic drug development

Guidances (Drugs) > Product-Specific Recommendations for Generic Drug Development
FDA has published 48 product-specific guidances (31 new and 17 revised) describing the Agency’s current thinking and expectations on how to develop generic drug products that are therapeutically equivalent to specific reference-listed drugs.
FDA always seeks feedback and considers all comments to the docket before it begins work on the final versions of product-specific guidances.

Product-Specific Recommendations for Generic Drug Development

To successfully develop and manufacture a generic drug product, an applicant should consider that their  product is expected to be:  pharmaceutically equivalent to its reference listed drug (RLD), i.e., to have the same active ingredient, dosage form, strength, and route of administration under the same conditions of use,  bioequivalent to the RLD, i.e., to show no significant difference in the rate and extent of absorption of the active pharmaceutical ingredient;  and, consequently,  therapeutically equivalent, i.e., to be substitutable for the RLD with the expectation that the generic product will have the same safety and efficacy as its reference listed drug. 
According 21 CFR 320.24, different types of evidence may be used to establish bioequivalence for pharmaceutically equivalent drug products, including in vivo or in vitro testing, or both. The selection of the method used to demonstrate bioequivalence depends upon the purpose of the study, the analytical methods available, and the nature of the drug product.  Under this regulation, applicants must conduct bioequivalence testing using the most accurate, sensitive, and reproducible approach available among those set forth in 21 CFR 320.24.  As the initial step for selecting methodology for generic drug product development, applicants are referred to the following draft guidance: Draft Guidance for Industry on Bioequivalence Studies With Pharmacokinetic Endpoints for Drugs Submitted Under an Abbreviated New Drug Application (ANDA) (Dec. 2013).
To further facilitate generic drug product availability and to assist generic pharmaceutical industry with identifying the most appropriate methodology for developing drugs and generating evidence needed to support ANDA approval, FDA publishes product-specific recommendations describing  the Agency’s current thinking and expectations on how to develop generic drug products therapeutically equivalent to specific reference-listed drugs.  
These recommendations are published in an incremental manner and listed below in alphabetical order according to RLD’s name. The most recently published recommendations (new and revised) are listed below.
The Agency is seeking feedback and considers comments to the docket on these recommendations. The comments should be submitted to the Division of Dockets Management (DDM) under Docket FDA-2007-D-0369-0015. For electronic comments, refer to the website http://www.regulations.gov OR mail your written comments to DDM (HFA-305), FDA, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852. Please contact the Regulations.gov Help Desk at 1-877-378-5457 (toll free) for assistance regarding submissions.
For additional information on development of generic drug products refer to Biopharmaceutics  
Bioequivalence Recommendations for Specific Products Arranged by Active Ingredient [Total count 1554]
A  B  C  D  E  F  G  H  I  J  K  L  M  N  O  P  Q  R  S  T  U  V  W  X  Y  Z
Newly Added Recommendations since Dec. 1, 2016 (31 New; 17 Revisions) updated 12/22/2016

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
 Draft Oral
Suspension, Extended Release
Draft OralCapsule20825312/2016

DraftIntramuscular, subcutaneousInjection1943012/2016
DraftOralCapsule, Delayed Release20465512/2016
selective hepatic intra-arterial
Injectable 12/2016
DraftOralTablet, Extended Release20654412/2016
DraftOralCapsule, Extended Release20809012/2016
DraftOralTablet, Extended Release20824612/2016

Newly Revised Bioequivalence Recommendations since Dec. 1, 2016

Active Ingredient
(link to Specific Guidance)
TypeRoute of AdministrationDosage FormRLD Application Number
(link to Orange Book)
Date Recommended
Acyclovir  (PDF - 85KB) Revised Draft TopicalCream, 5%02147812/2016

Albuterol Sulfate (PDF - 144KB) Revised
 Draft InhalationAerosol, Metered  12/2016
Draft SublingualFilm02241012/2016
Buprenorphine HCl; Naloxone HCl (PDF - 23KB)  Revised DraftOralTablet, Sublingual20424212/2016
Divalproex Sodium (PDF-19KB) RevisedDraftOralTablet, Delayed Release1872312/2016
Divalproex Sodium (PDF-19KB) RevisedDraftOralCapsule, Delayed Release Pellets1968012/2016
Divalproex Sodium (PDF-57KB) RevisedDraftOralTablet, Extended Release2116812/2016
DraftOralCapsule, Extended Release20416812/2016
Draft IntramuscularSuspension02024612/2016
Nepafenac (PDF - 73KB) RevisedDraftOphthalmicDrops, Suspension 0.1%2186212/2016
Nepafenac (PDF - 78KB)  RevisedDraftOphthalmicDrops, Suspension 0.3%20349112/2016
Omega-3-Acid Ethyl Esters (PDF - 82KB)  RevisedDraft OralCapsule2165412/2016
Venlafaxine HCl (PDF - 28KB) RevisedDraftOralTablet7669012/2016

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