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 Affairs, Publishing & Submissions, Regulatory Software & Services
- 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In July 2022, the United States Food and Drug Administration (US FDA) issued draft guidance titled ‘Human Prescription Drug and Biological Products - Labeling for Dosing Based on Weight or Body Surface Area for Ready-to-Use Containers - “Dose Banding.”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In September 2022, the United States Food and Drug Administration (US FDA) released a draft guidance document titled “Statement of Identity and Strength - Content and Format of Labeling for Human Non-prescription Drug Products.” The draft guidance aims to enhance the consistency of labeling for Over-the-Counter (OTC) drugs.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.
- November 22, 2022 Medical Devices, Regulatory Affairs
The need for continuous improvement in product quality, reliability, and safety arises due to recalls, updates of Regulatory requirements, and the desire to gain a competitive advantage. The newly introduced changes may alter the risk profile of the device, and the device manufacturers must revisit risk evaluations that pinpoint and reduce part or system failures over the product's lifecycle.
- November 21, 2022 Biologicals, Generics, Pharmaceuticals
DYK? The National Medical Products Administration (NMPA), along with China National Intellectual Property Administration (CNIPA), has released “Measures for the Implementation of Early Resolution Mechanisms for Drug Patent Disputes (Trial)." It is a patent registration platform for chemical drugs, biological products, and traditional Chinese medicines.