Navigating the Regulatory landscape can be a complex and time-consuming process for pharmaceutical and biotechnology companies. A crucial aspect of this journey is effective Regulatory submission management, which involves coordinating and monitoring timelines, adhering to best practices, and avoiding common pitfalls.
Innovations in drug-device combinations have led to significant advancements in patient care. Drug product(s) coupled with medical devices offer targeted drug delivery, improved therapeutic outcomes, and enhanced patient adherence. However, navigating the Regulatory landscape for drug-device combinations can be complex.
This blog will explore the considerations and challenges associated with the Regulatory operations for drug-device combination products, which offer insights into streamlining the processes.
A medical device Regulatory strategy is a plan for ensuring that a medical device meets all relevant Regulatory requirements before it is marketed and used in clinical practice. This typically involves conducting pre-clinical and clinical testing to demonstrate the device's safety and effectiveness and submitting the results to Regulatory authorities for review and approval.
The medical devices industry is considered as highly regulated. Hence, devising a right Regulatory strategy will be a potential approach and a great value-added contribution to avoid Regulatory roadblocks. Especially, medical devices manufacturers willing to launch their products in the ASEAN geographies have to walk through stringent regulations, as different markets portray different Regulatory requirements.
While the world is tussling with COVID-19 pandemic, there’s an emergency need for its treatments and vaccines. Though, currently, there is no FDA approved therapy or vaccine for COVID-19, the agency has several tools to expedite the review and approval of a COVID-19 biologic treatment or vaccine, after it emerges.
Registering a medical device with the FDA requires an apt submission pathway. In most of the cases, identifying and selecting a pathway is quite simple. For example, as discussed in our previous blog, if there exists a predicate for your medical device, then file a 510(k). If not or if your device is of class III, then file a pre-market approval (PMA). But is it always the case? Not necessarily.
It’s no strange for everyone who is into regulatory intelligence services that a well-proportioned regulatory strategy plays a key role in boosting the opportunity of regulatory approval. Now a regulatory plan is also equally important which helps in meeting the objectives of the regulatory approval process. Lately we’ve found out that many people get confused by both these terminologies.