USA – FDA finalizes guidance giving ANDA facilities time to comply with cGMP
The US Food and Drug Administration (FDA) will give generic drug manufacturers more time to bring facilities not fully compliant with its current good...
USA – FDA issues draft guidances covering BIMO inspections
The US Food and Drug Administration (FDA) has issued two draft guidances on bioresearch monitoring (BIMO) inspections. The first covers information to assist the...
USA – AAM seeks clarity, leeway in BA/BE studies guidance
The Association for Accessible Medicines (AAM) wants the US Food and Drug Administration (FDA) to clarify what its expectations of sponsors of bioavailability (BA)...
USA – Experts, FDA officials discuss future of clinical trials
Officials from the US Food and Drug Administration (FDA) and participants from the JAMA Summit on clinical trials recently highlighted the relationship between the...
USA – FDA plans to release AI drug development guidance this year
The US Food and Drug Administration (FDA) plans to release a draft guidance this year on the use of artificial intelligence/machine learning (AI/ML) to...
USA – FDA issues platform technology designation draft guidance
The US Food and Drug Administration (FDA) has published a much-awaited draft guidance detailing how it plans to implement its new platform technology designation...
USA – Stakeholders provide feedback on FDA draft guidance on drug development for early...
Guidance for developing drugs to treat early Alzheimer’s disease should focus on factors such as cognitive changes and brain atrophy, according to comments submitted...
USA – FDA unveils draft guidance on REMS logic models
The US Food and Drug Administration (FDA) has released a draft guidance outlining the agency’s risk evaluation and mitigation strategy (REMS) logic model.
FDA described...
USA – FDA exploring model master files to expedite generic drug development
The US Food and Drug Administration (FDA) is exploring the use of model master files (MMFs) to enable sponsors to use the same modeling...
USA – Emerging technologies and regulatory agency guidance for CGTs
Advances in cellular and gene therapies (CGTs) – referred to as advanced therapy medicinal products (ATMPs) in the EU – offer opportunities for treating...
