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Dec 20, 2014

Season's Greetings!


The whole Widler & Schiemann Ltd. team wishes you happy holidays and a successful and prosperous new year 2015!

FDAs Final Guidance for Industry
Patient Counseling Information Section of Labeling for Human Prescription Drug and Biological Products-Content and Format

From the Background description: "On January 24, 2006, FDA published a final rule that amended the requirements for the content and format of labeling for human prescription drug and biological products (commonly referred to as the physician labeling rule (PLR)).3 This rule created a new required section in labeling entitled PATIENT COUNSELING INFORMATION (ยง 201.57(c)(18)). The PATIENT COUNSELING INFORMATION section summarizes the information that a health care provider should convey to a patient (or caregiver when applicable) when a counseling discussion is taking place (e.g., a physician prescribing a drug during an office visit, a nurse providing discharge instructions at a hospital, or a pharmacist conveying information at a pharmacy)..."

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Another FDA Final Guidance for Industry
Providing Regulatory Submissions In Electronic Format -Standardized Study Data

From the Introduction: "This guidance and the technical specifications documents it incorporates by reference describe the requirements for an electronic submission of standardized clinical and nonclinical study data under section 745A(a) of the FD&C Act. In accordance with section 745A(a), following the issuance of a final guidance on this topic, study data contained in the submission types identified in this guidance must be submitted electronically in a format that FDA can process, review, and archive.

This guidance implements the electronic submission requirements of section 745A(a) of the FD&C Act for study data contained in new drug applications (NDAs), abbreviated new drug applications (ANDAs), biologics license applications (BLAs), and investigational new drug applications (INDs) to the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER)3 by specifying the format for electronic submissions. Submissions that are not submitted electronically and electronic submissions that are not in a format that FDA can process, review, and archive will not be filed or received, unless exempted from the electronic submission requirements

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And finally another FDA Final Guidance for Industry
Providing Regulatory Submissions in Electronic Format-Submissions Under Section 745A(a) of the Federal Food, Drug, and Cosmetic Act

From the Introduction: Section 745A(a) of the Federal Food, Drug, and Cosmetic Act (FD&C Act), added by section 1136 of the Food and Drug Administration Safety and Innovation Act (FDASIA) (Public 2 Law 112-144), requires that submissions under section 505(b), (i), or (j) of the FD&C Act and submissions under section 351(a) or (k) of the Public Health Service Act (PHS Act)3 be submitted in electronic format specified by the Food and Drug Administration (FDA or the Agency) beginning no earlier than 24 months after FDA issues a final guidance specifying an electronic submission format.

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