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.
EU Issues Study on REACH Implementation
August 6th 2009The Society of Chemical Manufacturers and Affiliates (SOCMA) reported in late July that Eurostat, the Statistical Office of the European Communities, recently published a baseline study or the first snapshot of REACH policy in the preregistration phase.
Extreme Rise in Drugs Detained by EU Authorities
July 23rd 2009A new report from the European Commission show a significant increase in the amount of intellectual property rights (IPR) infringements between 2007 and 2008, including a 57% increase in the number of counterfeit medicine cases between the two years.
FDA's Dr. Srinivasan Discusses Question-based Reviews for Generic Drugs
July 23rd 2009Two years ago, the US Food and Drug Administration's Office of Generic Drugs (OGD) developed and implemented a program to test question-based reviews for abbreviated new drug applications (ANDAs). OGD is reviewing the benefits and challenges faced by pharmaceutical firms involved in the initiative to see what changes need to be made going forward.
Senate HELP Committee Vote Favors 12-Year Exclusivity; BIO, GPhA, NVCA Weigh In
July 16th 2009This week, the Biotechnology Industry Organization (BIO) and the Generic Pharmaceutical Association (GPhA) issued their opposing statements in reaction the July 13 passage of an amendment from the US Senate Committee on Health, Education, Labor, and Pensions (HELP) regarding the creation of a pathway for the approval of new competitors of biologic drugs.
Organizations Recommend Priorities for Comparative-Effectiveness Research
July 9th 2009The Federal Coordinating Council for Comparative Effectiveness Research recommended that data infrastructure be the primary investment for the US Department of Health and Human Services's (HHS) comparative-effectiveness research (CER) funds.