miércoles, 2 de octubre de 2013

CDER Small Business Update: Meetings and New Guidance Documents

The Small Biz Buzz
The Information Source for Regulated Domestic and International Small Pharmaceutical Business
FDA/CDER's Small Business Assistance


1. US Conference on Rare Diseases & Orphan Products 2013 - October 7-9, North Bethesda, MD

At this annual conference, all stakeholders in the rare disease community - patients, patient organizations, researchers, drug and device companies, investors, thought leaders and government – meet to focus on rare diseases and orphan product research, development and access.  Previous meetings brought together more than 300 stakeholders. This year's event promises even more. You may register online or download a registration form.
Meeting information: http://www.diahome.org/en-US/Flagship-Meetings/RareDiseases2013.aspx


2. Guidance for Industry: ANDA Submissions ― Refuse-to-Receive Standards
This guidance is intended to assist applicants preparing to submit to FDA abbreviated new drug applications (ANDAs) and related submissions (i.e., prior approval supplements (PASs) for new strengths). The guidance contains details on what should be included in these submissions and highlights serious deficiencies that may cause FDA to refuse to receive the submission.
Federal Register Notice
Guidance Document

3. Draft Guidance for Industry on Bioanalytical Method Validation
This draft guidance is intended to provide recommendations regarding analytical method development and validation for the measurement of drugs and/or metabolites, therapeutic biologics, and biomarkers for sponsors of investigational new drug applications (INDs), new drug applications (NDAs), abbreviated new drug applications (ANDAs), and biologics.
Federal Register Notice
Guidance Document

3. Draft Guidance for Industry on Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format
This draft guidance is intended to assist applicants with developing the PATIENT COUNSELING INFORMATION section of labeling required under § 201.57(c)(18) (21 CFR 201.57(c)(18)). The recommendations in this guidance are intended to help ensure that this section of labeling is clear, useful, informative, and to the extent possible, consistent in content and format.
Federal Register Notice
Guidance Document

4. Guidance for Industry on Electronic Source Data in Clinical Investigations
This guidance provides recommendations to sponsors, Contract Research Organizations (CROs), clinical investigators, and others involved in the capture, review, and retention of electronic source data in FDA regulated clinical investigations. In an effort to streamline and modernize clinical investigations this guidance promotes capturing source data in electronic form, and it is intended to assist in ensuring the reliability, quality, integrity, and traceability of data from electronic source to electronic regulatory submission.
Federal Register Notice
Guidance Document

5. Draft Guidance for Industry on Endocrine Disruption Potential of Drugs: Nonclinical Evaluation

This draft guidance document provides recommendations to sponsors on the parameters that should be routinely assessed in toxicology studies for INDs, NDAs, and BLAs. This draft guidance also discusses factors to consider in determining the need for additional studies to characterize potential endocrine disruptor properties of a drug.
Guidance Document
Federal Register Notice

No hay comentarios: