⚖️Cerilliant Corporation's Application for Import of Controlled Substances
Cerilliant Corporation has applied to be registered as an importer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊Curia New York Applies for Controlled Substances Manufacturing Registration
Curia New York, Inc. has applied to be registered as a bulk manufacturer of basic class(es) of controlled substance(s). Refer to Supplementary Information listed below for further drug information.
Learn More💊FDA Issues Draft Guidance on Cancer Drug Combinations
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Development of Cancer Drugs for Use in Novel Combination--Determining the Contribution of the Individual Drugs' Effects." This draft guidance is intended for sponsors developing drugs for use in combination for the treatment of cancer and provides recommendations for characterizing the safety and effectiveness of individual drugs for use in a novel combination regimen in oncology (i.e., demonstrating the contribution of each drug to the overall effect that is observed for the population). This guidance expands on the recommendations in the 2013 guidance for industry entitled "Codevelopment of Two or More New Investigational Drugs for Use in Combination." This guidance does not address contribution of effect in settings where an investigational drug is being developed in combination with a drug approved for the same indication for the purposes of comparing the approved drug to the combination or to fixed combinations of previously approved drugs for the approved indication(s).
Learn More💊FDA Draft Guidance on Aluminum Content in Parenteral Nutrition Products
The Food and Drug Administration (FDA or Agency) is announcing the availability of a draft guidance for industry entitled "Small Volume Parenteral Drug Products and Pharmacy Bulk Packages for Parenteral Nutrition: Aluminum Content and Labeling Recommendations." This draft guidance is intended to clarify the key factors in calculating the aluminum content to ensure that the total aluminum exposure in parenteral nutrition (PN) does not exceed an acceptable threshold. It also provides FDA's recommendations regarding the aluminum concentration limits for small volume parenterals (SVPs) packaged as single doses or SVPs packaged in pharmacy bulk packages (PBPs). Additionally, this draft guidance is intended to assist sponsors and applicants in determining the appropriate placement of information on aluminum toxicity in SVP and large volume parenteral (LVP) Prescribing Information and container and carton labeling. This draft guidance revises and replaces the draft guidance for industry of the same name published on December 7, 2022.
Learn More💊FDA Patent Extension Notice for WINREVAIR
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for WINREVAIR and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human biological product.
Learn More💉NIH Proposes New Intellectual Property Policy for Cancer Research
The National Cancer Institute, an Institute of the National Institutes of Health, Department of Health and Human Services, Division of Cancer Prevention (DCP) is seeking comments on instituting a standard policy on Intellectual Property (IP) developed by certain funding recipients under NCI DCP funding agreements. This standard policy is entitled "The DIVISION OF CANCER PREVENTION INTELLECTUAL PROPERTY OPTION TO COLLABORATORS (IP Option)." The proposed policy, if finalized, shall apply to entities that conduct DCP-funded clinical studies under funding agreements which involve an NCI collaborator that provides its proprietary agent or technology for the DCP-supported studies where this IP Option is included as a term of applicable existing and future funding agreements.
Learn More💊Lilly del Caribe Receives FTZ Production Activity Authorization
The Department of Commerce's FTZ Board authorized production activity for Lilly del Caribe, Inc. in Carolina, Puerto Rico, under Foreign-Trade Zone (FTZ) regulations. The decision follows public comments and confirms compliance with relevant FTZ Act regulations, signifying growth opportunities in the pharmaceutical sector.
Learn More💊FDA Notice on Regulatory Review Period for FILSPARI Patent Extension
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for FILSPARI and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Learn More💊FDA Announces Regulatory Review Period and Patent Extension for AGAMREE
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for AGAMREE and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of applications to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Learn More💊FDA Notice on Patent Extension for EXEM FOAM
The Food and Drug Administration (FDA or the Agency) has determined the regulatory review period for EXEM FOAM and is publishing this notice of that determination as required by law. FDA has made the determination because of the submission of an application to the Director of the U.S. Patent and Trademark Office (USPTO), Department of Commerce, for the extension of a patent which claims that human drug product.
Learn More