M. Nielsen Hobbs
Executive Editor
Latest From M. Nielsen Hobbs
US FDA Pursuing Two-Track Approach To Regulatory Convergence For Cell and Gene Therapies
Discussions through the WHO are aimed at educating low- and middle-income countries, while efforts with ‘the larger regulators’ aim to reduce the development burden for products targeting ultra-rare diseases, CBER director Peter Marks tell DIA.
Peter Marks On How He Wants To Prepare For The Next Pandemic
Acknowledging the toll that vaccine opponents have taken on FDA operations, the CBER director emphasizes the need to create stand-by manufacturing capacity, conduct faster studies in special populations, and better understand the mRNA platform.
User Fee Bill Clears Senate Committee With Importation, Orphan Drug Amendments
Highlighting the much-less-bipartisan atmosphere than the House, ranking member Burr votes against the package; US FDA’s advice to generic applicants could be contentious issue in reconciling the legislation between the two chambers.
The Story of Aduhelm, From Early Studies To Commercial Demise
Our graphical timeline walks you through the most significant events in the history of the Alzheimer’s drug, including the tumultuous last year.
The Story of Aduhelm, From Early Studies To Commercial Demise
Our graphical timeline walks you through the most significant events in the history of the Alzheimer’s drug, including the tumultuous last year.
Podcast Special: Assessing US FDA Commissioner Robert Califf’s First 100 Days
Reporters and editors from the Medtech Insight and sister publications covering the pharmaceutical and health, beauty and wellness sectors look at Califf’s goals, accomplishments and trials during the early days of his second term.