Social media and other communication technologies are excellent instruments for bringing attention to public health issues and solutions. In addition, these contemporary tools are employed to disseminate misinformation and conspiracies regarding various subjects, such as vaccinations, genetically engineered organisms, climate change, and, most recently, the COVID-19 pandemic.
- September 2, 2022 Medical and Scientific Communication, Regulatory Medical Writing
- September 1, 2022 Medical Devices
Labeling is an integral part of marketing medical devices. The label is a piece of information affixed with the device and/or packaging in a human-readable format. The main purpose of labeling is to provide safety information to users who can be healthcare professionals, consumers, or any other relevant person.
- September 1, 2022 Pharmaceuticals, Regulatory Artwork Services
The rise in Tracking and Tracing (T&T) systems in the pharmaceutical industry can be attributed to the development of novel and patient-centric medicines. Over the years, T&T systems have improved medication for patients by transforming product handling processes without a quality compromise until it gets dispensed by integrating supply chain operations and technology use.
- September 1, 2022 Generics, Pharmaceuticals, Publishing & Submissions
In 2023, about fifty-one (51) drugs will get off-patented in the United States, opening the gates for generic drugs to claim a share of the expected expired drugs. Tracking the expiration of these drugs will help assess business opportunities and refine market entry strategies.
- August 30, 2022 Medical Devices
The 510(k)-clearance program, also known as Pre-Market Notification (PMN), is US FDA’s device review pathway to ensure safe and effective entry of medical devices into the US territory. US FDA requires manufacturers of the majority of Class II devices and a few Class I and III devices to obtain 510(k)-clearance.
- August 29, 2022 Regulatory Software & Services
On July 28, 2022, the EMA released an incremental update to the IDMP-SPOR implementation guide (IG). The latest version, 2.1.1, addresses a few gaps in product data definition, including corrections and clarifications.
- August 23, 2022 Biologicals, Pharmaceuticals, Regulatory Medical Writing
Medical writing refers to writing scientific documents by specific healthcare professionals for various purposes, including Regulatory submissions. The global medical writing market was valued at USD 3.6 billion in 2021 and is expected to reach USD 8.4 billion in 2030, growing at a CAGR of 10.41%. In 2021, North America ruled the market due to the growing number of drug trials and new drug approvals.
- August 12, 2022 Medical Devices
The US Food and Drug Administration (US FDA) has proposed to amend the medical devices Quality System Regulations (QSR) under 21 CFR 820. The current QSR regulations date to 1978 and have been amended only once in 1996. This action, if implemented, will align 21 CFR 820 more closely with ISO 13485:2016, the international consensus standard for devices widely accepted by global Regulatory Authorities.
- August 12, 2022 Regulatory Medical Writing
It is challenging for medical writers to ensure that their project’s content, style, and format are high quality. Even the best medical writers may make a mistake. Therefore, it is important to have a quality check of the documents. Quality Control (QC) experts look at a document with a set of “fresh eyes,” which can identify mistakes that an author might overlook. Hence, QC reviews are critical to Regulatory documents.
- August 12, 2022 Medical Devices
Companion Diagnostics (CDx) are In Vitro Diagnostic devices used in conjunction with therapeutic drugs to determine their suitability for the patients. To place the CDx in the European Union, the manufacturer is required to submit technical and other relevant documents to the Notified Body (NB) for technical and conformity assessment.