The adaptation of medical writing bloomed through the ever-evolving medical device industry coupled with the implementation of stringent regulations in the countries.
- January 17, 2023 Medical Devices, Regulatory Affairs, Regulatory Medical Writing
- January 17, 2023 Medical Devices, Regulatory Affairs, Regulatory Medical Writing
The clinical evaluation of medical devices is a procedure for demonstrating the safety and efficacy of the devices. The documentation of the clinical evaluation process is called a Clinical Evaluation Report (CER). The CER holds a significant position when placing or distributing medical devices in the European Union (EU).
- January 16, 2023 Medical Devices, Regulatory Affairs, Regulatory Labeling
The most significant and crucial step in the device approval process is the labeling aspect. The safe and proper use of medical devices by patients and those who provide care for patients depends on accurate labeling with all the necessary information to ensure market access.
- January 13, 2023 Publishing & Submissions, Regulatory Software & Services
eCTD submissions are one of the key steps in the development of pharmaceuticals. What if you miss your product launch due to a delay in eCTD submissions? The cost of lost opportunity per day delay in the product launch is expected to be in the millions. Subsequently, the cost of non-compliance to the Health Authority (HA) timelines and regulations is huge.
- January 10, 2023 Medical Devices, Regulatory Affairs
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 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.