regulatory intelligence

Applying regulatory flexibility in the age of COVID-19

A study by the Centre for Innovation in Regulatory Science has found that there are numerous regulatory routes that can be used to assess and authorise medical products during a public health emergency or pandemic. Although yet to be used extensively, these Emergency Use Pathways (EUPs) offer the regulatory flexibility needed to ensure that medical […]

Q&A: Five simple strategies to ensure regulatory compliance when globalizing your development program

Industry expert Lawrence Liberti shares his tips for tackling the complexity and diversity of regulatory requirements in divergent markets While expansion into new markets potentially introduces tremendous opportunities to scale your business, globalizing your development program doesn’t come without risks. Whether you’re a pharma or biotech from an established region looking to expand into an […]

Medtronic drives innovation, eyeing new products to stay on top

BioWorld MedTech™, the global medical device news service from Clarivate Analytics, developed a series of articles on how key companies in the industry approach innovation. Below is an excerpt from the profile of Medtronic plc. Click here to access to the full series. Medtronic plc is the largest pure-play med-tech company in the world by […]

Boost in Paragraph Four patent challenges drives competitive generics marketplace

Much attention has been given recently to the volume and pace of generic drug approvals by the FDA as that agency has prioritized increasing competition in the market to control costs.  Less attention has been given to the number of first-time Abbreviated New Drug Applications (ANDAs) and the outlook for competition in those generic drug […]

Sublocade approval likely to be a game changer in the U.S. fight against opioid addiction

This article is a Clarivate Analytics Market Insight report, an ongoing series featuring expert reviews of hot topics in the pharma/biotech field, with analysis and discussion on the factors currently affecting the industry. Data leveraged for this analysis was gathered from Clarivate Analytics Cortellis. According to the latest National Survey on Drug Use and Health […]

Shifts in the FDA’s Approach to Off-Label Promotion

The Regulatory Affairs Professionals Society (RAPS) held its annual conference, the RAPS Regulatory Convergence, from September 17-20 in San Jose, CA. Clarivate Analytics Medical/Regulatory Writer Meg Egan Auderset attended; she wrote the following based on a session called The Changing Landscape of Off-Label Promotion.

Advances in Alzheimer’s, but Knowledge Gaps Remain

The Regulatory Affairs Professionals Society (RAPS) held its annual conference, the RAPS Regulatory Convergence, from September 17-20 in San Jose, CA. Clarivate Analytics Medical/Regulatory Writer Meg Egan Auderset attended; she wrote the following is based on a session about Alzheimer’s disease, Delivering the Next Generation of Alzheimer’s Treatments: Are We Prepared?