The European Medicines Agency published a question-and-answer document for assessors of periodic safety update reports, or PSURs, as a part of good pharmacovigilance practices. Source: Drug Industry Daily
Medicare Part D beneficiaries could shop for drugs at more pharmacies and take advantage of cheaper new generics sooner under revised rules proposed by the Centers for Medicare and Medicaid…
An FDA advisory committee voted Thursday to not recommend two regimens for Bayer’s inhalation-powder formulation of ciprofloxacin for the treatment of non-cystic fibrosis bronchiectasis, citing inconsistent data from clinical trials.…
The Senate gave final congressional approval to a bill designed to resolve a dispute involving FDA and the Department of Defense, preserving FDA’s authority over authorizing innovative medical treatments for…
A sweeping tax overhaul bill approved by the House in a 227-205 vote Thursday would eliminate the orphan-drug tax credit, although the version of the legislation up for Senate consideration…
The FDA unveiled its new regenerative medicine oversight framework — the regulation of promising stem cell treatments, engineered tissues and cell therapies — by publishing four guidance documents focused on…
A major manufacturer of generic drugs in India failed to follow up as required on laboratory tests that showed its products at two facilities did not meet specifications, in some…
The FDA could further improve the transparency of its benefit-risk assessments in drug regulatory decisions by disclosing more information in complete response letters, BIO suggested in written comments to the…
The European Medicines Agency should upgrade its user testing of drug packaging inserts and other product information for patients over the next 18 months in carrying out recommendations from the…
The FDA published a draft guidance explaining the new biosimilar fee structure under BsUFA II and the types of fees that took effect Oct. 1. The draft also covers how…