The establishment of European Union Medical Devices Regulations (EU MDR) 2017/745 and In Vitro Diagnostic Devices Regulations (EU IVDR) 2017/746 posed additional requirements. The significant aspect highlighted was implementing the Post-Market Surveillance system (PMS). Enabling PMS will ensure the devices' safety even after being launched in the market.
- January 10, 2023 Medical Devices, Regulatory Affairs
- January 6, 2023 Medical Devices, Regulatory Affairs
In-Vitro diagnostics (IVD) are products that are reagents, instruments, or systems that can detect diseases or other conditions and monitor a person’s overall health to help cure, treat, or prevent diseases.
The classification of an IVD determines the appropriate premarket process for approval. The FDA classifies IVD products into Class I, II, or III based on the associated risk.
- January 6, 2023 Generics, Publishing & Submissions, Health Authority Updates
The United States Food and Drug Administration (US FDA) released guidance in December 2022, a revision of the guidance titled ‘Failure to Response to an ANDA Complete Response Letter (CRL) Within the Regulatory Timeframe Guidance for Industry,’ of July 2022.
- January 6, 2023 Generics, Pharmaceuticals, Regulatory Affairs
The introduction of high-quality and reasonably-priced generic drugs in the market is a prevalent challenge for multiple Health Authorities. Several countries are taking steps to address this issue and make more generic drugs available in the market, consequently increasing the competition at a global level.
- January 6, 2023 Publishing & Submissions, Regulatory Software & Services
In a recent conference held by the USFDA, Drug Master File (DMF) Workshop: GDUFA III Enhancements and Structured Data Submissions - the FDA discussed two (02) topics, namely -
- January 4, 2023 Publishing & Submissions, Regulatory Software & Services
Regulatory submissions and publishing tasks have traditionally been laborious involving hours of manual efforts for formatting documents, generating agency-compliant PDFs, doing quality checks, assembling documents for submissions, etc. With the demanding timelines, life science companies always rush for timely submissions.
- January 4, 2023 Medical Devices, Regulatory Affairs
1. What is the FDA Q-submission program?
Q-submission FDA program refers to the system that tracks the collection of interactions with the FDA. It helps manufacturers of Medical Devices and in vitro diagnostics (IVDs) to obtain feedback from the FDA regarding Regulatory processes and requirements for the product during its development.
- January 3, 2023 Pharmaceuticals, Health Authority Updates
China’s pharmaceutical sector is witnessing changes and advancements frequently. In a recent shift, the National Medicinal Products Authority (NMPA) has made electronic certificates for drug registration in China possible. This has been done as an initiative to deepen the reform of the pharmaceutical market and drug supervision. The declaration was given by the NMPA under announcement no.
- December 26, 2022 Pharmaceuticals, Regulatory Artwork Services, Regulatory Affairs
Counterfeit medicine is a major issue all around the world. It is estimated that a significant portion of a pharmaceutical products is counterfeit, and this figure is increasing yearly. Counterfeit drugs endanger the reputation and revenue of legitimate pharmaceutical firms as well as the public's health and safety.
- December 23, 2022 Regulatory Affairs, Publishing & Submissions, Regulatory Software & Services
A multitude of challenges are faced by the Regulatory departments by the move from paper-based to eCTD submissions that continues around the world. Most of the life science companies are struggling hard to keep up with the USFDA standard in using eCTD format and meet the specified deadline.