In a global marketplace with more than 7,100 spoken languages, manufacturers need to consider the local language and culture when developing medical device product labels. How does one make it possible to reach out to a diverse group of people?
- November 30, 2022 Medical Devices, Regulatory Affairs
- November 29, 2022 Pharmacovigilance, Pharmaceuticals, Regulatory Affairs
Marketing Authorization Holders (MAHs) with medicinal products authorized for marketing in the European Economic Area (EEA) have a legal responsibility of establishing a PV system for accomplishing PV obligations for their products. To this end, the MAHs in the European Union (EU) must appoint an appropriately qualified person for PV (QPPV). The role and responsibilities of the QPPV include, but are not limited to:
- November 29, 2022 Regulatory Affairs, Publishing & Submissions, Regulatory Software & Services
Since 2003, eCTD has been accepted by several Health Authorities around the world. Its standard has evolved incrementally over time. Based on the Health Level Seven (HL7) standard called RPS (Regulated Product Submission), eCTD 4.0 brings in major changes and introduces certain substantial updates.
- November 29, 2022 Regulatory Labeling, Health Authority Updates
In July 2022, the United States Food and Drug Administration (US FDA) issued draft guidance titled ‘Human Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding.” It is to help sponsors include dose banding information in drug labeling for ready-to-use containers…
- November 29, 2022 Regulatory Labeling, Health Authority Updates
In September 2022, the United States Food and Drug Administration (US FDA) released a draft guidance document titled “Statement of Identity and Strength - Content and Format of Labeling for Human Non-prescription Drug Products.” The draft guidance aims to enhance the consistency of labeling for Over-the-Counter (OTC) drugs.
- November 24, 2022 Regulatory Affairs, Regulatory Labeling
A drug therapy regimen is diverse for drugs that can be approved to be used in combination with a previously approved drug or simultaneously developed two novel drugs, that synergistically enhance efficacy. Single-drug cancer therapies significantly showcased drug resistance as a major threat for patients undergoing treatments with anti-cancer drugs.
- November 24, 2022 Medical Devices, Regulatory Affairs
510(k) is a premarket submission made to the FDA to demonstrate that the device to be marketed is as safe and effective, that is, substantially equivalent to a legally marketed device (predicate). Devices with moderate risk are required to submit a 510(k) notification, which includes a minority of Class I and III devices and a majority of Class II devices.
- November 24, 2022 Medical Devices, Regulatory Affairs
Class A IVDs under European Union In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/745 require self-certification. The manufacturer is required to self-declare their product’s compliance with the EU IVDR’s requirements and affix the CE marking.
- November 24, 2022 Medical Devices, Regulatory Affairs
What is an eCopy?
An eCopy is an electronic version of your medical device submission created and submitted on a compact disc (CD), digital video disc (DVD), or flash drive. An eCopy is accompanied by a paper copy of the signed cover letter. It is to be noted that an eCopy is not the same as a Food and Drug Administration (FDA) electronic submission [PKJ1]. Following are submissions that require an eCopy:
- November 22, 2022 Medical Devices, Regulatory Intelligence, Regulatory Software & Services
The medical device industry is undergoing continuous transformation to comply with the ever-changing Regulatory guidelines introduced by global Regulatory authorities to ensure strict controls over device performance and safety.