As we all know, the FDA will first evaluate the potential risk of a medical device before it is launched in the USA. The evaluation is done through a risk-based classification process to ensure the device’s safety, quality, and efficacy. The low-risk Class I devices require only general controls, and the high-risk Class II devices are subject to special controls and require more Regulatory scrutiny and oversight.
- November 15, 2021 Medical Devices
- November 12, 2021 Pharmaceuticals, Regulatory Affairs
The need for life-saving drugs is on a constant rise. Owing to novel diseases proving fatal, drug manufacturers are spending a lot of time and money on the research and development of chemical and biological drugs. As challenging as inventing Innovator drugs is, it can be equally daunting for manufacturers to register them.
- November 11, 2021 Medical Devices
As we all know, there are continuous updates to the existing technologies alongside the advent of new ones. Incorporating these technologies into the drug-device combination products for tracking and monitoring purposes is increasing day by day.
- November 10, 2021 Medical and Scientific Communication, Regulatory Medical Writing
Communication through digital media vastly influences the perception of consumers regarding a product/service. Hence, pharmaceutical firms are constantly evolving to achieve a fair balance while advertising their products. Regulators, on the other hand, monitor the quality and authenticity of the data being published.
- November 10, 2021 Chemicals, Regulatory Affairs
Recently, the U.S. Environmental Protection Agency (EPA) revised the Lead and Copper Rule (LCR) to protect children and communities from the risks of lead exposure. EPA aims to get the lead out of the drinking water and empower communities through the correct information. According to the recent revision, the new rules includes the following improvements:
- November 9, 2021 Pharmaceuticals, Regulatory Labeling
Recently, Per the revised Manual of Policies and Procedures (MAPP) of the United States Food and Drug Administration (USFDA) has proposed new labeling rules under Section 505(j)(10) of the Federal Food, Drug, and Cosmetic Act (FD & C Act). This Section covers the FDA’s approval of an Abbreviated New Drug application (ANDA) even after a few changes in the labeling for the Reference Listed Drug (RLD).
- November 8, 2021 Pharmaceuticals, Regulatory Affairs
After the initial discovery of nitrosamine impurities in drugs and Active Pharmaceutical Ingredients (APIs) by the USFDA in mid-2018, the EU Regulatory bodies have also joined many other countries in a bid to prevent the risks involved. They have re-called several medicines that post health perils from the substance.
- November 3, 2021 Pharmacovigilance, Pharmaceuticals
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is an international non-profit organization that strives to maintain an updated database to summon Regulatory Agencies and pharmaceutical manufacturers to discuss scientific and technical aspects of the industry on a single platform.
- November 3, 2021 Biologicals, Regulatory Affairs
Biologicals are booming as therapy and have significantly become an established treatment option to provide ailment to niche disease segments which seemed impossible earlier. COVID-19 pandemic has made researchers keen to develop biosimilar and interchangeable products for the patient population at an affordable price.
- October 26, 2021 Pharmaceuticals, Regulatory Affairs, Publishing & Submissions
China has established its position as a manufacturing hub for pharmaceuticals. Innovation in manufacturing techniques has encouraged China to explore the scope of research and development for medicinal preparations. The National Medical Products Association (NMPA) looks after the safety of drugs, medical devices, and biologics along with their regulation by undertaking their standards’ management.