Learn how an Abbreviated New Drug Application (ANDA) helps generic drugs get FDA approval without clinical trials, ensuring safety and bioequivalence with brand-name drugs.

As the US Food and Drug Administration publicizes its plans to overhaul the process for manufacturers that want to market medical devices in the United States, a year-long investigation by a nonprofit ...

It’s a long and arduous process that requires tons of data. Plus, the agency wants to rebuild trust after coming under attack during the Trump Administration. While nearly 190 million Americans have ...

President Donald Trump on Labor Day asserted that a coronavirus vaccine could be ready "during the month of October" — just weeks before the November 3 presidential election. Given that it typically ...

The Food and Drug Administration (FDA) has begun accelerating the process to fully approve the Pfizer-BioNTech COVID-19 vaccine, facing pressure to add resources from those who believe the lack of ...

The challenge of bringing an idea from the concept stage to the marketplace is one every startup faces. In the MedTech space, there is the added layer of effort needed to ensure the safety and ...

The answer may surprise you. The Food and Drug Administration (FDA) plays a key role in the development of new biopharmaceutical products. In particular, the FDA provides an essential public service ...

One in 10 babies in the U.S. is born premature, with elevated rates of disability and death. For almost a decade, a drug called Makena has been used to reduce the risk of further instances of early ...

President Biden is yet again facing backlash over the FDA’s booster approval process, which recommended boosters for children this week without convening a panel of advisors to weigh in on the matter.

This is one of a series of interviews by Bloomberg Opinion columnists on how to solve the world’s most pressing policy challenges. It has been edited for length and clarity. Max Nisen: In November, a ...

The FDA appointed George Tidmarsh, MD, PhD, to be the nation's top drug official in July. The Center for Drug Evaluation and ...

Dublin, Oct. 28, 2025 (GLOBE NEWSWIRE) -- The "Biopharmaceutical Manufacturing Process Validation (Nov 17th - Nov 18th, 2025)" training has been added to ResearchAndMarkets.com's offering. This ...