Controlled substances are highly regulated and must be vigilantly monitored from the laboratory to the marketplace to prevent theft and illicit sale in the black market, a growing trend. In 2011 there were 36 cases of pharmaceutical cargo theft in the United States at an average value of more than $500,000 per incident. Abundant federal and state regulations, plus increased globalization – with its stringent import and export restrictions, permits and declarations required for controlled substances – has made compliance even more challenging. Partnering with a contract development and manufacturing organization (CDMO) experienced in supply chain management of controlled substances, from Schedule II and III through to V, can prevent costly delays, steep penalties for regulatory noncompliance, and the potential postponement of a clinical trial.
Patricia Hurley, Joan Boren and Costantino Congiatu, PPD||June 2, 2015 More than $60 billion worth of patents on biological products are expiring before 2020, representing a major opportunity for the pharmaceutical industry.
Stephanie Mowery, Sherri Rinker, Franklin Spriggs and Bo Kowalcyk , AIT Bioscience||June 2, 2015 Moving forward clinical studies will have to include a comparative assessment of
pharmacokinetics and immunogenicity to the original reference biologic drug
December 11, 2014 A cheese manufacturing company in Wisconsin had been using static spray balls to clean their mozzarella and provolone cooling baths and was frustrated with the slow, inefficient process.
October 28, 2014 Market research estimates performed in the last 6 months have shown that the market size for
ophthalmic medications is expected to reach more than 25 billion, by the year 2015. The ophthalmology
drugs market classification is based on the type of drugs: treatment-based drugs, over-the-counter (OTC)
drugs and ocular anesthetics.