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Several medical devices use either off-the-shelf or custom software. A couple of guidance documents from FDA written almost a decade ago are the only official comments from FDA to assist manufacturers understand the current FDA requirements. Despite a long history of software usages in medical devices, there is significant confusion regarding updating software applications in new 510(k) devices and the additional testing requirements. The level of details expected in a 510(k) application is very different from what used to be 10 years ago. This webinar will discuss the structure and level of detail required in filing a 510(k) when a medical device is software or contains software.

Attend this webinar to learn about when you require a premarket approval for a medical device and FDA approval process for medical devices.

The Office of Device Evaluation (ODE) receives approximately 6500 Premarket Notification (5100) submissions every year. Many of these submissions are incomplete or grossly inadequate, as they fail to contain the components necessary to allow substantive review of the submission and inappropriately consume Center resources. As a means to employ more effectively the Center's resources, the FDA has implemented procedures to ensure that 5 10Ks meet a minimum threshold of acceptability; otherwise the Center will refuse to accept the submissions for substantive review.

"The global pharmacovigilance market size is expected to reach USD 11.64 billion by 2026. It is projected to expand at a CAGR of 13.3% during the forecast period. Increasing incidence of Adverse Drug Reactions (ADR) is the key growth driver. The U.S. Food and Drug Administration (FDA) received approximately 253,017 serious adverse events and 44,693 deaths associated with ADRs in 2015. This shows the potential demand for implementing safety and Pharmacovigilance (PV) services."

The global breast cancer drug market size is expected to reach USD 38.4 billion by 2025. It is projected to expand at a CAGR of 10.7% during the forecast period. Early detection, increase in awareness, and incidence of breast cancer are some of the key trends stoking market growth. Global breast cancer drugs market is expected to grow lucratively as many players focus majorly on R&D of innovative treatments. They engage in extensive research to develop novel drugs for the treatment of the disease to gain a higher market share. There exists a growing pressure and need for novel therapies and treatment due to rapidly accelerating prevalence of diseases. The strong pipeline is expected to provide new and effective treatment options and improved outcomes than existing therapies. With advancements in drug delivery systems, various target specific therapies have been customized and designed as a carrier to infuse the therapeutic agent to the target site. Carriers for inducing target therapy include modified anticancer agent's specific to molecular-recognition-element, anticancer peptides, and nanoparticle-based anticancer drugs. For instance, HER2/neu protein is usually given in combination with other anti-cancer drugs in targeted therapy. Get Free Sample Copy of this Report at at: https://www.radiantinsights.com/research/breast-cancer-drugs-market/request-sample F. Hoffman-La Roche Ltd leads the breast cancer drugs market with Herceptin, Perjeta, and Kadcyla. However, rapid advancements in biosimilars with a goal to offer cost effective alternatives to patients is anticipated to put pressure on this space. For instance, in December 2017, the Food and Drug Administration (FDA) approved the first biosimilar of trastuzumab for HER2+ breast cancer. Further key findings from the report suggest: * HER2 inhibitors is expected to be the most preferred drug class segment over the forecast period, owing to their high specificity as they are subclass of target therapy *

Learn about various product approval processes, product development and regulatory filing strategies focusing on 505(b)(2) pathway.

In this webinar Rotimi Toki will explain the inside knowledge about Gluten, how to get labelled on our product as Gluten-Free, gmps rules and more.