Management of the business-government relationship is critical for firm performance in regulated industries. In this paper, we predict a U-shaped between product complexity and time to approval by US Food Drug Administration (FDA). Moreover, argue that association contingent on types strategic alliances (i.e., R&D alliance, Marketing alliance) focal those help FDA pharmaceutical companies a...

The petitioner requests that the Commissioner of the Food and Drug Administration declare that the drug product Divalproex Sodium Extended-Release Tablets, 1000 mg, is suitable for submissiol as an ANDA. The reference-listed drug product upon which this petition is based is Depakote ER (Divalproex Sodium) Extended-Release Tablets, 500 mg manufactured by Abbott Laboratories. The approval of whic...

The comparison of drug product selection rates determined approximately one year and four years after passage of Florida's Drug Product Selection (DPS) Law indicates very little change in the product selection and brand interchange behaviors of Florida pharmacists. Lack of adequate guidelines from the state and the liability concerns of pharmacists appeared to limit an expected increase in the ...

Short-term back orders and long-term unavailability of drug products have been a challenge to pharmacy managers for many years. Nevertheless, these drug product shortages have been increasing in frequency and severity since the late 1990s. The causes are varied and involve all segments of the “supply chain.” Changes in policies and practices among these segments individually and collectively co...

Natural products (NPs) have historically been a fertile source of new drugs for the pharmaceutical industry. However, this once-popular approach has waned considerably over the past two decades as the high-throughput screening of megalibraries comprised mainly of molecules with non-natural (synthetic) motifs has unfolded. Contemporary high-throughput screening libraries contain molecules compli...

FDA drug package inserts provide comprehensive and authoritative information about drugs. DailyMed database is a repository of structured product labels extracted from these package inserts. Most salient information about drugs remains in free text portions of these labels. Extracting information from these portions can improve the safety and quality of drug prescription. In this paper, we pres...