The US Food and Drug Administration (FDA) is confronted with significant challenges in its inspection processes due to recent layoffs. Among ...

The US Senate Judiciary Committee advanced to the full Senate six bills intended to reduce pharmaceutical prices and enhance market competitiveness. The package collectively targets several aspects of ...

According to market estimates for 2024 to 2034, demand for regulatory information management systems is likely to register a ...

The agency is missing deadlines and not responding to biotech companies, forcing some to push back clinical trials.

The ban was issued after the regulator found that some FDC drugs were licensed for manufacture, sale and distribution without ...

CDSCO directs States to halt sale of unapproved FDC drugs, emphasizing safety and compliance with drug regulations.

The regulatory body issued the directions after it found that certain FDC drugs have been licenced for manufacture, sale, and ...

One attorney said the ruling “isn’t quite the stake in the heart.” The FDA is unlikely to challenge the court’s decision, but ...

The memorandum of agreement involving Inmar Intelligence was the end result of 18 months of negotiations after the DEA said in an October 2023 news release that it had launched ...

This blog delves into the rise of rare disease drug approvals and the critical importance of regulatory guidance in shaping ...