FDAnews Drug Daily Bulletin Pharmaceuticals / Postmarket Safety / Submissions and Approvals Generics Demand Stronger Proscriptions in REMS Compliance Letter Guidance Generic drugmakers charge a December draft guidance doesn’t go far enough in enabling them to obtain...
Nobody likes to part with money – in business or otherwise. That being said, the idea of GDUFA fees makes sense. Long term, the fees are expected to fund faster review times, induce a higher level of compliance and safety, and even eliminate the submission of hollow...
In an unexpected reception fit for a king, China based API manufacturing facility, Jinan Jinda Pharmaceutical Chemistry Company, honored President and CEO of ChemWerth, Peter Werth as not only an industry “Pioneer and Mentor” but also as a “Philanthropist and Friend.”...
On August 2nd, the FDA published the Facility Fees for Fiscal Year 2015 and as anticipated they have increased from FY 2014. Due on October 1, 2014, the FDA has provided a high level overview of what is expected and the consequences of not following through on this...
While the globalization of our business has posed both opportunities and challenges, companies that can demonstrate a track record of success and product excellence are thriving while those that are lacking are being weeded out. Your company’s reputation as a high...
As per the June 2013 draft guidance ANDAs: Stability Testing Drug Substances and Products, the FDA intends on using the ICH Stability Guidelines as a benchmark for ANDA and DMF Type II submissions. Initially this was set to take effect January 1, 2014. However, with...
