regulations

Regulatory response to the COVID-19 pandemic: Fast tracking therapeutics

The efforts to end the COVID-19 pandemic have been multifaceted: epidemiological data for understanding, vaccines and non-pharmaceutical interventions for prevention, and new or repurposed drugs for treatment.  In this blog post, Monia Tumminello, Manager, Cortellis Regulatory Intelligence™, and Jaime Polychrones, Medical Writer, Cortellis Regulatory Intelligence, discuss the regulatory response to therapeutic development, from issuing new […]

Regulatory response to the COVID-19 pandemic: Prevention via non-pharmaceutical intervention

Preventive strategies for COVID-19 include a variety of non-pharmaceutical interventions (NPIs) such as social distancing and the use of personal protective equipment (PPE). Reliable case identification and contact tracing guide the distribution of supplies and implementation of NPIs. In this blog post, we discuss how regulatory agencies have addressed the ongoing need for NPI, PPE, […]

Regulatory response to the COVID-19 pandemic: Careful planning to minimize disruptions

Beyond the need to address the ongoing pandemic itself, regulators also must address the impacts to clinical trials as well as essential supplies of treatments and medicines for other diseases and conditions. In this final blog post of our series, we describe strategies to minimize disruption to ongoing clinical trials, drug manufacturing and essential supplies […]

Device industry looks to cut time to market

German medical device companies are growing concerned that the approval process in Europe for bringing innovative products to market is taking too long, especially when compared with the U.S., according to a survey conducted by the German medical technology association. In Australia, meanwhile, the Therapeutic Goods Administration (TGA) reported shorter approval timelines for new devices […]

Big data: The future in healthcare is sooner than we think

Data is, of course, driving the future of healthcare. Stakeholders across the industry have been widely preparing for the Big Data transformation and how to put the data to best use. At the recent Financial Times Global Pharmaceutical and Biotechnology Conference titled “Embracing Disruption for a New Era in Health,” several experts examined how to […]

New medical device regulations: The view from Europe

The increased globalization of the medical device landscape was a recurring theme as the industry gathered in Philadelphia for the MedTech Conference this fall. Sessions looked at recent regulatory and business developments in several key markets including Brazil, China, India and the U.S. Here is a look at one important panel discussion that took place […]

Med-techs extend borders seeking new opportunities

Medical device companies, eager to drive growth, are now increasingly seeking new opportunities – and approvals from regulators – throughout the world. Three recent examples of companies extending their reach across borders include: U.S.-based Abiomed garnering approval in India for three heart pumps; I. Ceram, a French company, achieving CE mark certification in Europe for […]

Global push in med-tech innovation prompts regulatory reviews and upgrades

In country after country, regulatory review and change in the med-tech industry have become a constant. Authorities are “advancing with the changing health care landscape,” as one industry representative put it, striking an upbeat note on recent regulatory updates around the world. In China, authorities seek to streamline reviews and approvals to drive innovation and […]