The Food and Drug Administration (FDA) announced a new proposal Monday for flexible drug approval pathway treatments addressing ultrarare diseases. The FDA unveiled draft guidance on a proposed ...

With a goal of avoiding unnecessary duplication of studies performed on a previously approved drug, the 505(b)(2) pathway allows for a more streamlined development and approval process, but for new ...

San Diego – Officials from the European Medicines Agency (EMA) discussed the different types of expedited approval pathways available to sponsors of innovative drugs and advanced therapy medicinal ...

In the second part of our FDA: Drug & Device Team’s series on biological products regulation, we discuss the regulatory pathways for biological products under Section 351 of the Public Health Service ...

FDA is proposing the PM pathway largely in response to concerns from patient advocates and industry stakeholders that FDA’s existing product approval pathways lack sufficient flexibility for ...

After teasing a new regulatory process for personalized genetic medicines at the end of last year, the FDA today unveiled draft guidance for an approval pathway that could see custom CRISPR therapies, ...

A new UK drug approval pathway, designed to speed up the availability of new medicines, benefits industry over patients and the NHS, argues an expert in The BMJ today. The pathway aligns regulatory ...

(The Hill) — The Food and Drug Administration (FDA) on Monday announced a new proposal for flexible drug approval pathway treatments addressing ultra-rare diseases. The FDA unveiled draft guidance on ...