Article Consumer Products Food and Beverage FDA Proposes Seventh and Final FSMA Rule After the rise of major outbreaks of foodborne illnesses and bioterrorism concerns, FSMA was signed into law to direct food ...
Article Consulting Services Generics Proposed Labeling Rule Has Serious Implications for Generics Industry The FDA has recently proposed new labeling requirements for generic pharmaceutical companies. Current regulations do not allow generics companies to ...
Article Generics Consulting Services Generics Manufacturers Not Liable for the Design of Drugs In the case of Mutual Pharmaceutical Co. Inc. v. Bartlett, the Supreme Court overturned a lower court ruling that awarded ...
Article Generics Consulting Services Pay-for-Delay and the Rule of Reason The economics of pay-for-delay agreements are clear – branded drug makers benefit from an extended amount of time on the ...
Article Biotech Contract Manufacturing FDA’s Final Rule on Combination Products Combination drugs continue to grow in popularity as novel alternatives and advances in biotechnology, pharmaceuticals and medical devices. The market ...
Article Biotech Consulting Services Europe’s Drug Pricing Approach Creates Challenges Austere times in Europe continue to challenge local governments to reduce healthcare spend. Leveraging Europe’s reference pricing policies, Eurozone countries ...
Blog Post Quality + Compliance Contract Manufacturing To Serialize or Not to Serialize – That’s no longer the question Most Pharma companies have been taking a “wait and see” approach to starting a Serialization and Traceability initiative, hoping that ...
Article Biotech Generics FDA Reform Bill Heading Towards Obama The 2012 FDA reform bill, which includes a fifth, five-year reauthorization of the Prescription Drug User Fee Act (PDUFA V), ...