FDA says it has not received any petitions to request an exemption from the 100% supplement ingredient identity testing requirement. Food and drug attorneys say the hassle of preparing a petition for a waiver outweighs the potential benefits
The hurdles that dietary supplement firms must clear to obtain waivers from the 100% ingredient identity testing requirement in GMPs are discouraging firms from applying, despite the incentive of reduced testing costs, according to experts.
FDA says that no supplement manufacturers have applied for the waivers. While the waivers are optional, the agency expected firms...
A Johnson & Johnson executive tells the Pink Sheet in an interview how the company developed its pretzel-shaped intravesical drug releasing system for gemcitabine, which used design and materials to improve efficacy and ease bladder cancer treatment.
The former CDC director and recently departed chief medical officer tell senators that Kennedy plans to target the childhood vaccine schedule despite a lack of scientific data to support his agenda.
The FDA said new molecular entity application reviews increased and cost less in fiscal year 2024, a potentially encouraging sign for industry.
The Give Kids A Chance Act would renew the PRV program that began to sunset in December 2024. The House Energy and Commerce Committee advanced the pediatric- and rare disease-focused package, but also included generic drug transparency provisions.
The Give Kids A Chance Act would renew the PRV program that began to sunset in December 2024. The House Energy and Commerce Committee advanced the pediatric- and rare disease-focused package, but also included generic drug transparency provisions.
Recently released CRLs for unapproved products contain recommendations for new studies, including design element details and advice to consider different submission pathways.
The US FDA may ask sponsors for permission to train AI models using data from new drug applications. Alternatives to animal testing could be a test case.
