In today’s fast-paced environment, everything needs to be done right the first time. This is especially important when releasing pharmaceutical and biological products to the market. To accomplish this, firms employ a special group of quality professionals, called the batch review/release group, to review executed batch records and be that all-important final sign-off for release to market. This is no easy task. Much of the time, these executed batch records are many pages long with complex information and data to review for accuracy. Effective and efficient management of this review process is the key to a successful process.
Pharmaceutical companies are experiencing a significant change because of the shift in drug development toward more complex and expensive cell therapies with a focus on rare diseases.
FDA inspectors continue to observe CGMP violations involving data integrity during CGMP inspections of laboratory operations. At least 20 percent of all warning letters issued by the CDER Office of Manufacturing Quality in 2017 included explicit observations by inspectors of blatant data integrity violations in laboratory operations. While there has been an increase in warning letters issued to firms in China and India for flagrant data integrity violations, firms in the United States, Europe, and Japan have also been cited with similar violations.
As the gene and cell therapy sector develops and its products start to move from development to commercial manufacture, the requirement for the technology transfer of these products will only increase. This technology will transfer from smaller or academic establishments and development laboratories, to larger facilities with greater capacity in-house, or to a partner company or CMO. It can occur at any phase of a product’s life cycle, from R&D preclinical stages to post-Phase 3 clinical trials to full commercial production.
The hurricane season of 2017 will be remembered as one of the worst, with some of the strongest tropical cyclones ever witnessed creating havoc in the Atlantic basin.
This article presents a detailed summary of the drug GMP warning letters issued in FY2017, as well as a comparison of trends since fiscal year 2013. A comprehensive GMP intelligence program includes evaluation of health authority enforcement actions, including FDA Forms 483, warning letters, seizures, recalls, and consent decree agreements.
To be entitled to a patent, an invention must satisfy a number of patentability requirements, including the “patent eligibility” requirement under 35 U.S.C. § 101. Part 1 and Part 2 of this three-part series reviewed the origin and history of the patent-eligibility requirement and jurisprudence and how the U.S. Supreme Court’s decisions since Mayo Collaborative Services v. Prometheus Labs, Inc. significantly raised the patent-eligibility bar, and examined the impact of Mayo on life sciences patent litigation in lower courts.
Not a day goes by when we don’t learn of yet another application for mobile phones in healthcare. The list includes using mobile phones to diagnose and manage health-related conditions, to monitor subjects participating in clinical trials, and to conduct remote consultations with physicians and other caregivers.
Since 1983, pharmaceutical developers have been incentivized by the FDA via an Orphan Drug Designation (ODD) program to develop products to treat rare diseases and/or conditions. The program awards orphan status to drugs that show likelihood of benefitting an afflicted population that might not otherwise be the focus of targeted development efforts. To meet the FDA’s specific requirements, sponsors have found specificity matters. Though other steps in a drug’s life cycle require a wider scope, when it comes to defining the orphan population and making a case for the drug’s potential efficacy in that population, a razor-focused effort is key.
To be entitled to a patent, an invention must satisfy a number of patentability requirements, including the “patent eligibility” requirement under 35 U.S.C. § 101. In Part 1 of this three-part series, we reviewed the origin of the three “patent ineligible” subject matters, the evolution of the U.S. Supreme Court’s jurisprudence on the issue, and how the Supreme Court’s decision in Mayo Collaborative Services v. Prometheus Labs, Inc. changed the patent-eligibility landscape for life science patents.