Government regulations affect drug development, often prolonging the process, but they ensure safety and efficacy to protect ...

Developing high-quality, safe, and effective drugs is a complex process that requires varied scientific skills and stringent regulatory assessments. Drug development is a process that spans many years ...

The U.S. Food and Drug Administration (FDA) announced a new process called “Rare Disease Evidence Principles” (RDEP), under which eligible drugs and biologics for ultra-rare diseases caused by known ...

An FDA draft guidance nixing the requirement for biosimilar manufacturers to conduct comparative efficacy studies may prove ...

The Food and Drug Administration (FDA) development and approval process for drugs and medical devices involves multiple phases that ensure the safety and effectiveness of products before and after ...

Six weeks after a reduction in force (RIF) at the US Food and Drug Administration removed thousands of workers, signs are emerging about how the agency’s approach to drug approval may change. The 20% ...

The FDA has granted priority review status for pegcetacoplan (Empaveli) to treat two rare kidney diseases that can lead to kidney failure. Up until now, there hadn’t been any drugs approved ...

PharmTech spoke with Dr. Asma Patel, VP Global Commercial and Scientific Consulting–Drug Product, to find out how the growth ...

The FDA has proposed new policies to speed up the development and lower the cost of biosimilar agents for cancer and other serious illnesses. These policies include “major updates to simplify ...

The U.S. Food and Drug Administration on Thursday introduced the Rare Disease Evidence Principles (RDEP) to provide greater speed and predictability in the review of therapies intended to treat rare ...

In Darwinian terms, survival isn’t a matter of being the biggest, the fastest, or the strongest of the species, but instead ...

The U.S. Food and Drug Administration (FDA) announced on Wednesday (October 29) a plan to streamline the approval process for biosimilars, which are generic versions of complex biological drugs. These ...