Author | Jill Wechsler

Jill Wechsler is ACT's Washington Editor

Articles

FDA Speeds New Guidances to Inform Clinical Research During Pandemic

The need for new therapies to treat coronavirus patients has prompted an onslaught of advisories from FDA clarifying how sponsors should assess and implement changes necessary to fit this new reality.

Do Biosimilars Require Clinical Trials?

Pharmaceutical Executive

Experts are proposing more limited clinical trials for follow-on therapies in some situations, particularly for critical oncology drugs and for highly targeted treatments for rare conditions. Jill Wechsler reports.