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Posted December 20, 2019

SILVER SPRING, MD—The FDA approved 1,171 generic drug products during the 2019 fiscal year, exceeding the 2018 record of 971 approvals. Also, 125 of the approvals were for first generics of medicines that had no generic competition, including an emergency opioid overdose treatment and drugs to treat conditions such as pulmonary arterial hypertension, breast cancer, seizures, depression, and various infections.

Posted December 20, 2019

MOUNT PROSPECT, IL—The FDA has awarded a cooperative agreement grant to the National Association of Boards of Pharmacy (NABP), allowing the group to establish an information-sharing system for drug compounding activities, which are primarily overseen by states. The three-year pilot project will focus on improving the information available to state regulators and the FDA about state-licensed entities that engage in drug compounding and distribute compounded drugs across state lines. The project’s overall goal is to provide more-targeted regulation and oversight of compounded drugs and reduce patient risk.

Posted December 20, 2019

SILVER SPRING, MD—The FDA’s Center for Drug Evaluation and Research (CDER) has reorganized the New Drugs Regulatory Program, requiring restructuring of the Office of New Drugs (OND) to create offices that align interrelated disease areas and divisions with more focused areas of expertise. The changes increased the number of OND offices that oversee review divisions from six to eight and the number of OND clinical divisions from 19 to 27 in addition to adding six non-clinical review divisions. The OND will also create cross-functional support offices of New Drug Policy, Drug Evaluation Sciences, Regulatory Operations, Operations, and Administrative Operations.

Posted December 20, 2019

RESTON, VA—The Association for Packaging and Processing Technologies (PMMI) welcomed 41 new members during the organization’s annual meeting in November, bringing the total active membership to 927. PMMI is a global resource for the packaging and processing industry that aims to unite the industry across the manufacturing supply chain

Posted December 20, 2019

SILVER SPRING, MD—In November, the FDA published 105 product-specific guidances (PSGs), which provide recommendations for developing generic drugs and generating the evidence needed to support ANDA approval. The published guidances include revisions of previous PSGs as well as new guidances for complex products, products with no currently approved ANDAs, and complex and non-complex NCEs. The new batch brings the total number of PSGs to more than 1,750.

Posted December 20, 2019

SILVER SPRING, MD—The FDA has launched an internet-based platform called CURE ID that allows professionals in the clinical community to use the website, a smartphone, or other mobile device to report their experiences treating infectious diseases using existing FDA-approved drugs in novel ways. The platform captures clinical outcomes when drugs are used for new indications, populations, doses, and/or combinations, facilitating crowdsourcing of medical information from healthcare providers to guide potentially life-saving interventions and the development of new drugs for neglected diseases. The platform is a result of a collaboration between the FDA and the National Center for Advancing Translational Sciences (NCATS), which is part of the National Institutes of Health (NIH).