guidance for industry - rx-360

Federal Register :: Use of Symbols in Labeling

See Guidance for Industry and FDA Staff entitled "Frequently Asked Questions on Recognition of Consensus Standards" (Ref 1) Because manufacturers are not limited to use of stand-alone symbols which are part of an FDA-recognized standard the final rule should not present the challenges raised by the commenters

Data Integrity Library

IVT Network Data Integrity – FDA and Global Regulatory Guidance October 2014 NSF Journal Issue 28 Spring 2014 Data Integrity A Modern Day Challenge Rx-360 Data Integrity Checklist _China Working Group Audit Checklist Dinesh Thakur slide deck from Rx-360 Annual meeting November 2016 Medassure: Securing the Supply Chain Dinesh Thakur

Capital Rx Appoints Josh Golden As SVP Of Strategy

2019-11-25With over a decade of experience as a strategic consultant in the healthcare industry Josh will assess market trends evaluate business initiatives and develop strategic partnerships to support the continued growth of Capital Rx Previously Josh served as Area Senior Vice President at Solid Benefit Guidance a division of Arthur J Gallagher

Five Steps to Medical Device Commercialization

2014-10-1Applying Human Factors and Usability Engineering to Medical Devices – Guidance for Industry and Food and Drug Administration Staff In addition the FDA has also issued draft guidance documents and seeks feedback from industry on their content The recent draft guidance documents of interest to manufacturers of Internet-based devices include:

Standardization of Data and Documentation

On February 28 2018 FDA issued draft guidance on Standardization of Data and Documentation Practices for Product Tracing This draft guidance aims to provide trading partners information to appropriately track product information through the pharmaceutical distribution supply chain in compliance with requirements that took effect in 2015 as part of section 582 of the Federal Food

Federal Register :: Medical Devices Exemptions From

2020-8-7These factors are discussed in the January 21 1998 Federal Register notice and subsequently in the guidance we issued on February 19 1998 entitled "Procedures for Class II Device Exemptions From Premarket Notification Guidance for Industry and Start Printed Page 44187 CDRH Staff" ("Class II 510(k) Exemption Guidance")

SoCal Bio and ASQ / Food Drug Cosmetic Division "FDA

2016-9-2related legislation regulations guidance and industry compliance enforcement trends Barbara was the first chairperson of the Rx-360 Monitoring and Reporting work group (2009 to 2014) that summarized and published relevant GMP and supply chain related laws regulations and guidance She also served as the

Summaries Archives

Classification of Products as Drugs and Devices Additional Product Classification Issues: Guidance for Industry and FDA Staff EMA Implementation plan for the introduction of the safety features on the packaging of centrally authorised medicinal products for human use

Federal Register :: Medical Devices Exemptions From

2020-8-7The Food and Drug Administration (FDA or the Agency) is publishing an order setting forth the Agency's final determination to exempt a list of class II devices from premarket notification (510(k)) requirements subject to certain limitations This exemption from 510(k) subject to certain

Guidance for Industry

2020-9-10Guidance for Industry Circumstances that Constitute Delaying Denying Limiting or Refusing a Drug Inspection U S Department of Health and Human Services Food and Drug Administration Office of Regulatory Affairs (ORA) Center for Drug Evaluation and Research (CDER) Center for Biologics Evaluation and Research (CBER)

TeleTargetRx is a pharmaceutical tele detailing CRM platform specific to the industry It enables organizations to deliver the right message to the right target as well as offering requests for Rx samples and/or collateral material via a cost-effective alternative to sales representative detailing Read more

Eyewear for Medical Providers That Fitz a Need

Available in Rx and non-Rx this custom-fitted 3D printed eyewear hugs the contours of the wearer's face and provides enhanced droplet protection in a clinical setting Following guidance from the American Academy of Ophthalmologists that doctors refrain from using contact lenses the design is the result of a fast iterative process in direct

Health Plan Partners

As one of the industry's most affordable infectious disease laboratories we are dedicated to transparent billing practices and in-network with over 200 regional and national health plans Save time and money by eliminating the need for repeat testing Our methodology is more efficient and less expensive than traditional repeat culture We deliver fast accurate and actionable results to

China: NMPA Drug Traceability Guidance

2020-10-9First rather than the government contractor-run central repository from the old approach the new one forces the industry to create most of the infrastructure "5 2 1 1 The participants of drug traceability information system shall actively participate in the construction and maintenance of the drug traceability information system in

China: NMPA Drug Traceability Guidance

2020-10-9First rather than the government contractor-run central repository from the old approach the new one forces the industry to create most of the infrastructure "5 2 1 1 The participants of drug traceability information system shall actively participate in the construction and maintenance of the drug traceability information system in

Eyewear for Medical Providers That Fitz a Need

Available in Rx and non-Rx this custom-fitted 3D printed eyewear hugs the contours of the wearer's face and provides enhanced droplet protection in a clinical setting Following guidance from the American Academy of Ophthalmologists that doctors refrain from using contact lenses the design is the result of a fast iterative process in direct

Integrating the Global GDPs into the

2018-5-16Rx-360 Summary of IPEC GDP Guide to Control and Monitoring of Storage x x x x x x x x x x x x x x x x European Medicines Agency: QP EU Guidelines on Good Distribution Practice of The IPEC Good Distribution Practices Guide Europe - Good Distribution Practices Audit Austrian GDP Regulations Czech Republic Guidelines for Correct Distribution

FDA Draft Guidance: How To Apply For A Waiver

2020-10-13Last week the FDA finally published their draft guidance for submitting a waiver exception or exemption from certain Drug Supply Chain Security Act (DSCSA) requirements Originally the latest possible date FDA could delay publishing this particular guidance was May 31 2017 That is 180 days before the manufacturer's serialization and

Standards

2020-10-13TA Standards include disease-specific metadata examples and guidance on implementing CDISC standards What is Controlled Terminology? CDISC Controlled Terminology (CT) is the set of CDISC-developed or CDISC-adopted standard expressions (values) used with data items within CDISC-defined datasets

Regulatory References

2020-10-10Guidance for Industry Non-Clinical Studies for the Safety Evaluation of Pharmaceutical Excipients Guidance Compliance Regulatory Information Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specification

Home

Rx-360 creates awareness and understanding among its member companies of important issues related to quality and supply chain Rx-360 not only provides a network of collaboration among its members on common issues plaguing the healthcare industry but also provides a most needed service as part of its joint-audit program

FDA Draft Guidance: How To Apply For A Waiver

2020-10-13Last week the FDA finally published their draft guidance for submitting a waiver exception or exemption from certain Drug Supply Chain Security Act (DSCSA) requirements Originally the latest possible date FDA could delay publishing this particular guidance was May 31 2017 That is 180 days before the manufacturer's serialization and

Pharmaceutical Supply Chain Security Risk

Rx-360's Supply Chain Security Working Group has also looked at the total cost of loss seeking to justify a positive return on investment to offset program costs The "Guidance for Industry Q9 Quality Risk Management" document issued by the International Conference on Harmonization (ICH) 2 also referenced in the EU GDP guideline

Guidance for Industry and FDA Staff: Current Good

Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products that FDA issued on January 22 2013 (final rule)

Cost

2020-10-11Rx-360 International Pharmaceutical Supply Chain Consortium Centers for Medicare Medicaid Services requirements IPIECA Oil and Gas Industry Guidance on Voluntary Sustainability Reporting Renewable Volume Obligation (RVO) International Union for Conservation of Nature (IUCN) Protected Areas

VIA HAND DELIVERY Re: Rx

Rx-360 plans to implement two separate supplier audit programs specifically: (i) the sharing of supplier quality audits conducted by or on behalf of individual Rx-360 members (Rx-360 Audit Sharing Program) and (ii) the performance of joint quality audits of pharmaceutical suppliers (Rx-360

Quality Agreement Guideline Template

2018-5-18The "Rx-360 Best Practices Quality Agreement Guide" (reference 2) released in January 2016 constitutes a comprehensive guidance document that is intended to assist both customers and suppliers in efficiently managing the initiation negotiation implementation The "