Elijah Wreh, in Medical Device Regulation, 2023 Combination products A combination product is a product comprised of two or more regulated components (drug/device or biologic/device or drug/biologic) that are combined as a single entity or is a product labeled for use with a specified drug, de...
It focuses on the impact of the proposed regulation of the FDA to the combination products, or those products containing medical devices embedded with pharmaceutical or biologic components, in the Federal Register. It states that the new rules guide the medical device manufacturers depending upon the...
Introduced by the European Commission under the Medical Devices Regulation (MDR), Article 117 requires manufacturers placing drug-device combination products onto the market as an integral device and marketing them as a “medicinal product” to seek a Notified Body Opinion (NBOp). ...
Overview Combination product Regulation and CTD dossier requirments: EU and US (A comparative review) Lecture 2: Clarifying the regulatory requirements of combination products and addressing life-cycle management • Examining the regulatory requirements for drug device combinations in the case of a drug...
The MHRA has already stated in its most recent advice that it intends to “take into consideration international standards and global harmonisation” in the development of any future system of medical device regulation. And that they will “identify and prioritise elements of international practice ...
UBM Canon's portfolio of events for the healthcare manufacturing sectors includes MD&M, MEDTEC, BIOMEDevice and Pharmapack. UBM Canon also publishes a multitude of industry magazines, including Medical Device and Diagnostic Industry, Medical Product Manufacturing News, European Medic...
Product Differentiation: The Prize for the Winning Drug–Device Combination Pharmaceutical Technology Editors November 17th 2010 To find out about the regulatory, formulation, and manufacturing considerations involved in developing a new device to deliver a drug, Equipment and Processing Report talked to ...
Simplify the Journey With a Combination Product Solution Download Here Download Here Blog Human Factors Considerations for Combination Products – Recent FDA Guidance View Blog View Blog Blog FDA’s Final Rule Overview of Quality System (QS) Regulation/Medical Device Current Good Manufacturing Practices ...
inhalation, and injectable delivery systems. She also supports Scientific Affairs for Aptar Pharma. Dr. Suman directs the research division that supports product development and regulatory submissions for North American and International Clients in the pharmaceutical, biotechnology and medical devic...
15. Li Z et al, “Development and inhalation properties of Amikacin Liposome Inhalation Suspension (ALIS) for treatment of Mycobacterium avium complex (MAC) lung infections”. Drug Delivery to the Lungs Conference, Dec 2019. 16. “Applying Human Factors and Usability Engineering to Medical Devices...