Quality & Compliance

Two of the most vital aspects of the regulatory profession, Quality & Compliance examines the ins and outs of achieving both while still keeping other factors in mind for a successful regulatory experience.

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5 February 2014

New EU Regulation on Postmarketing Surveillance of Cosmetic Products

By Darshan Bhatt

This article highlights the cosmetic industry’s responsibilities for designating a single point of contact, collecting and reporting serious undesirable effects (SUEs), maintaining records and submitting Cosmetics Product Safety Reports (CPSRs) under the Cosmetics Regulation. Read More...


7 January 2014

Mutual Benefits of Industrial Design and IEC 62366

By Ryan Lee

Recent industry guidelines such as IEC 62366 and HE75 show an increasing obligation for medical device manufacturers to adopt a user-centered design approach. This article provides an overview of recent guidelines and explains how they can strengthen efforts to integrate human factors engineering into all phases of medical device design.

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30 October 2013

HCEI: Is Industry any Closer to a Clear Definition of Adequate Evidence?

By Richard Lem, PharmD

Sixteen years after the passage of FDAMA, one section of the law is still a subject of much debate within the industry: Section 114, which outlines the standard of evidence the pharmaceutical industry must meet to promote healthcare economic information (HCEI). Read More...


16 July 2013

Global Tracking Regulations Present Challenges and Benefits

By Torben Vogt and Mari Serebrov

Drug makers are facing an ever-increasing challenge as more countries implement serialization and tracking regulations and set compliance deadlines in an effort to ensure the safety and quality of prescription drugs being sold within their borders. Complying with regulations coming into effect will be a demanding task due to a lack of global harmonization. Read More...


11 July 2013

Medical Device Corrective and Preventive Actions

By Devin McBlair

Medical device companies are required by law to have corrective and preventive action (CAPA) procedures to identify, prevent and correct product quality nonconformities. The effectiveness of a CAPA procedure can make the difference between successfully resolving deficiencies and enduring recurring deficiencies that result in waste, inefficiency, customer dissatisfaction and, potentially, patient-related adverse events. Read More...


26 June 2013

Communicating Important Drug Safety Messages: the Dear Health Care Provider Letter

By Mary Sullivan

During a prescription drug’s lifecycle, new safety information frequently emerges that may affect its benefit:risk profile in some patients and require changes in the product labeling. One mechanism used by pharmaceutical sponsors to promptly communicate new drug information to US prescribers is the “Dear Health Care Provider” (DHCP) letter. Read More...


20 June 2013

Patient Testimonial Videos: FDA Actions on Risk Information Presentation

By Dale A. Cooke

Marketers frequently develop patient testimonials for promoting prescription products. At the same time, the US Food and Drug Administration (FDA) has taken numerous enforcement actions against the use of patient testimonials for product promotion. In the process, the agency has clearly designated as inappropriate certain ways of presenting risk information. This article addresses what companies can learn about presenting risk information correctly in patient testimonial videos, based on FDA guidance and enforcement actions, to ensure the resulting promotional material is compliant. Read More...


9 May 2013

Good Clinical Practice: Where Ethics and Quality Meet

By Jim Moran, Erika Stevens and Julie Statzel

This article discusses the history and primary principles of Good Clinical Practice (GCP), explaining that is much more than just a single document outlining the standards for clinical research. Read More...


4 April 2013

The Research Pharmacy: Quality Management System Approach for Common Noncompliance Issues

By Jim Moran, Erika Stevens and Christina Eberhart

Consider the following hypothetical situation: During a routine inspection, FDA requests and inspects investigational pharmacy policies and procedures as well as product accountability and handling. Were investigational products accounted for and stored appropriately? Does the investigational pharmacy have a quality management system or risk management policy? How are corrective and preventive actions tracked? Will the investigational pharmacy be cited with a Form 483? Read More...


7 August 2012

Comparing Drug Master File Procedures in Highly Regulated Markets

By S.K. Sahu, MPharm, PhD, and P.K. Nandi, MPharm

Drug Master Files (DMFs) are required in most countries as supporting documents for the registration of drug products. DMFs generally contain information pertaining to the chemistry, manufacturing and controls (CMC) sections of the drug submission and reflect the drug’s identity, strength, purity and quality. Read More...


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