Issue link: https://www.e-digitaleditions.com/i/1199406
10 January 2020 Tablets & Capsules FDA approves 1,171 generics in 2019 SILVER SPRING, MD—The FDA approved 1,171 generic drug products during the 2019 fiscal year, exceed- ing 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 treat- ment and drugs to treat conditions such as pulmonary arterial hyperten- sion, breast cancer, seizures, depres- sion, and various infections. FDA considers novel excipient review program T he F DA is seeking infor ma- tion and comments on a proposal to establish a pilot prog ram for assessing the toxicology and qual- ity of novel excipients outside the context of an IND, an NDA, or a BL A . Suppor ters of the prog ram state that certain novel excipients may provide public health benefits and believe that the agency's rec- ognition of a novel excipient would from 19 to 27 in addition to adding six non-clinical review divisions. The OND will also create cross-func- tional support offices of New Drug Policy, Drug Evaluation Sciences, Regulatory Operations, Operations, and Administrative Operations. NABP receives FDA grant for information-sharing project MOUNT PROSPECT, IL—The FDA has awarded a cooperative agree- ment grant to the National Associa- tion 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 pro- vide more-targeted regulation and oversight of compounded drugs and reduce patient risk. PMMI membership reaches new high RESTON, VA—The Association for Packaging and Processing Tech- nologies (PMMI) welcomed 41 new members during the organization's annual meeting in November, bring- ing 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. OND reorganization creates new offices and divisions S I LV E R S PR I N G , M D —T he FDA's Center for Drug Evaluation and Research (CDER) has reorga- nized the New Drugs Regulator y Program, requiring restructuring of the Office of New Drugs (OND) to create offices that align inter- related 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 Customized Fill Release in Gelatine Soft Capsules Revolutionary Release Fast release and reduced cross-linking Reliable Release Reduced cross-linking Standard Release Improved shelf-life and stability Release profile Enteric Release One-step-production of truly enteric capsules GELITA USA · Sioux City, IA · www.gelita.com · service.na@gelita.com