The US FDA has published more than 200 complete response letters sent as replies to drug and biological product applications.

The FDA published a database of letters sent to drugmakers during the review process of medications that provide information on the agency's initial feedback or requirements for more data. These ...

West Berkshire Council has decided to keep secret the names of people who lodge comments on planning applications. The Lib ...

The FDA has published more than 200 complete response letters, sent as replies for applications submitted from 2020 to 2024.

U.S. Rep. Mark Alford (R - 4th District) sent a letter to USDA Secretary Brooke Rollins expressing his support for COVID-era food programs.

The letters, many of which were already available online, detail why the regulators initially declined to approve some drugs.

To the editor, After 40 years, Wallingford welcomed a new mayor—and wow, did we choose well. Mayor Vincent Cervoni hit the ground running, proving that fresh leadership can bring both energy and ...

The proposal has no green spaces, not enough parking, and the building will be a sidewalk distance away from Route 7 and ...

The U.S. Food and Drug Administration on Thursday publicly shared over 200 archived so-called complete response letters related to medicines that were later approved, in a bid to improve transparency ...

Many independent scientists were unhappy with the format and their understanding of the commissioning process, and indeed sent me letters stating so.

An 82-year-old woman has been tested positive for Covid in Nahan Medical College of Sirmaur district in Himachal Pradesh. This is the state’s first case of the latest surge. As per the ...

Some Richmond neighborhoods remain under a boil water advisory after the city's water treatment plant experienced an operational issue early Tuesday that temporarily reduced water production.