The US Food and Drug Administration (FDA) has revised a 2023 draft guidance on master protocols for drug and biological ...
Adhering to quality by design (QbD) principles and employing risk-based monitoring strategies should reduce the likelihood of ...
European groups have raised questions about how patient preference studies (PPS) can be adapted from one region to another under the International Council on Harmonization (ICH) E22 guideline. Similar ...
The European Parliament has called for the temporary suspension of plans to make drugmakers pay for wastewater treatment.
The US Food and Drug Administration (FDA) is seeking comments on a pilot program where qualified external institutions will ...
The US Food and Drug Administration (FDA) has issued warning letters to a device maker and several drug makers for failing to ...
Welcome to another installment of This Week at FDA, your weekly source for updates – big and small – on FDA, drug and medical device regulation, and what we’re reading from around the web. This week ...
Officials from the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) said that increased ...
Regulatory Recon is our regular intelligence briefing for the regulatory affairs space, bringing you the top regulatory, ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing.
Welcome to Regulatory Reconnaissance, your regulatory news and i ...
The US Food and Drug Administration (FDA) says two marketing videos submitted by Pinnacle Biologics make misleading statements about the company's cancer drug Photofrin (porfimer sodium), noting that ...
Some results have been hidden because they may be inaccessible to you
Show inaccessible results