Real reason behind cancelled Nov. 3 advisory committee meeting relates to secondary hypogonadism indication, company says, not concerns about analytical validation as FDA claimed.
FDA's decision to cancel an advisory committee review of Repros Therapeutics Inc.'s hypogonadism treatment enclomiphene may have more to do with agency uncertainties about the proposed indication and appropriate population than its stated reason related to analytical validation issues, the company said.
Repros announced Oct. 29 that FDA's Division of Bone, Reproductive and Urologic Products cancelled a Nov. 3 advisory committee review...
The new CDER director focused on plans to improve morale during an Aug. 8 townhall, but staff comments indicate that may be a challenge.
Eli Lilly's CEO argued that pricing reforms aimed at existing drugs would be “hard to sustain or justify,” while other companies suggested a growing interest in direct-to-consumer sales programs.
New CDER Director George Tidmarsh promised to keep politics out of drug approvals, but suggested during a meeting with staff that he could not insulate the drug center from political pressures coming from those above him.
Companies in Europe cannot delay business decision making much longer to wait for more certainty on major US policy shifts on tariffs and pricing.
HHS' culling of mRNA vaccine projects under BARDA will heavily impact pandemic preparedness. Tiba Biotech was even “caught off guard” by its inclusion, because its project was neither a vaccine nor mRNA-based.
The program would allow early interactions with FDA staff to speed construction and approval of pharmaceutical manufacturing facilities in the US, but will staff be available?
Quantitative estimates of the safety risks with opioid pain medication, including the risk of addiction and misuse, must be added to labeling.
