March 14th 2025
The certification allows Benuvia to produce pharmaceutical products for companies, either local to Brazil or international, that may be looking for compliant and high-quality production capabilities in the Brazilian pharmaceutical market.
Grassley Investigates Drugmakers' Whistleblower Policies
July 8th 2010Last week, Senator Charles Grassley (R-IA) sent letters to 16 drugmakers, including Pfizer (New York), AstraZeneca (London), and Eli Lilly (Indianapolis), asking them about their current policies regarding whistleblowers?employees who file complaints under the False Claims Act (FCA).
FDA Issues Draft Guidance on CMC Postapproval Changes for Annual Reports
July 1st 2010The US Food and Drug Administration issued on June 25 a draft guidance for industry, "CMC Postapproval Manufacturing Changes Reportable in Annual Reports," to provide recommendations to drug applicants about the types of changes that may be included in annual reports.
HHS Report Recommends Improvements to FDA's Regulation of Foreign Clinical Trials
July 1st 2010The Office of the Inspector General for the Department of Health and Human Services (HHS) issued a report, Challenges to FDA's Ability to Monitor and Inspect Foreign Clinical Trials, which evaluates the incidence of foreign clinical trials, the ability of the US Food and Drug Administration to oversee these trials, and recommendations to FDA on how to improve its oversight of foreign clinical trials.
EMA Database Aids Safety Monitoring
June 3rd 2010A study conducted by the European Medicines Agency (EMA) has shown that statistical methods using EMA's EudraVigilance database of adverse drug reaction reports can be used to detect drug safety issues "significantly earlier" compared with routine pharmacovigilance.
FDA Testifies to Congress Regarding J&J Recalls, Quality Concerns
June 3rd 2010About one month after the announcement of McNeil Consumer Healthcare's recall of children's liquid pain and allergy medications , the US Food and Drug Administration testified before the US House Committee on Oversight and Government Reform about the issue.