Even with recent letters, Office of Prescription Drug Promotion’s slow pace continues from 2014’s record low.
FDA’s Office of Prescription Drug Promotion’s workload is getting lighter in one area: it is finding fewer objectionable promotional pieces. This year the office has issued only two letters to drug sponsors for making inappropriate claims about their products.
The low number of enforcement letters continues a downward trend since the agency’s record high of 51 letters in 2010....
Mexico’s drugs regulator will be able to grant quicker drug approvals based on decisions issued by World Health Organization listed authorities and founding ICH members.
Biogen has U-turned on its original decision not to file Qalsody for marketing approval in the UK for treating certain patients with amyotrophic lateral sclerosis. The move appears to have been triggered by a change in the reimbursement pathway agreed for the product.
Just a week and a half into his tenure at the agency, the new CDER Director George Tidmarsh was also tapped to serve as acting head of CBER. Prasad’s swift ouster at CBER may point to a softening in cell and gene therapy regulation but could also portend even more scrutiny on vaccines.
