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.
FDA Issues Draft Guidance on Presenting Risk Information in Promotional Materials
May 28th 2009The US Food and Drug Administration posted a draft guidance for industry, Presenting Risk Information in Prescription Drug and Medical Device Promotion, on its website May 26, that describes factors the agency considers when evaluating advertisements and promotional labeling for prescription drugs and medical devices.
European Commission Investigates Biotech Industry
May 21st 2009More than 70% of biotechnology executives fear that the European Commission's (EC) examination of anticompetitive behavior in the pharmaceutical industry, which began in January 2008, will weaken their patent protection, according to a new Marks & Clerk report.
Bill Would Give FDA Resources for Inspections
April 30th 2009Senators Chuck Grassley (R-IA) and Ted Kennedy (D-MA) introduced legislation last Thursday that would give the US Food and Drug Administration more resources to inspect domestic and foreign plants that manufacture drugs and medical devices.
PhRMA Defends Sustainability and Waste Management Practices
April 30th 2009The Pharmaceutical Research and Manufacturers of America released a statement this week in response to recent media reports regarding the amount of pharmaceutical ingredients being discharged by manufacturing facilities into the environment.
FDA Issues Guidance on Summaries for CTD-based Submissions
April 23rd 2009The US Food and Drug Administration finalized a Guidance for Industry this week that aims to clarify the submission of new drug applications (NDAs) and biologics license applicants (BLAs) using the common technical document (CTD) format, including the electronic CTD (eCTD).