Pharmaceutical Outsourcing covers news of importance to the contract services segment of the pharmaceutical industry.
Collected from the most trusted on-line resources, these news stories are chosen and published here based on their relevance to the pharmaceutical industry.
Topics of interest typically include: mergers and acquisitions, service additions, new capabilities, personnel changes, news from the FDA and other international regulatory and standard-setting agencies, and new outsourcing contracts and deals.
If you are looking to stay up-to-date with the news in your industry, this resource is vital for your industry knowledge.
Wednesday, February 26, 2020
The FDA is upgrading the Purple Book in phases with full search functionality for all approved biosimilar products and their reference products.
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CN Bio announced that the FDA has extended their research collaboration, for a further three years.
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Tuesday, January 17, 2023
CN Bio announced that the FDA and CN Bio have expanded their collaboration for the second time, with new research aiming to evaluate multi-organ MPS and their applications using the PhysioMimix™ Multi-organ System.
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The U.S. Food and Drug Administration (FDA) has approved an expansion to the IMBRUVICA® (ibrutinib) U.S. Prescribing Information (PI) based on data supporting its use in patients with chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL),...
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Wednesday, September 09, 2015
The FDA is expanding its alert regarding compounded or repackaged drugs stored in Becton-Dickinson (BD) general use syringes to include certain additional syringe sizes including 1mL, 10mL, 20mL and 30mL BD syringes, and BD oral syringes.
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Friday, February 15, 2019
The FDA has issued a final rule under section 503A of the FDCA, placing six bulk drug substances on the list of substances that compounders can use to compound drugs, known as the 503A bulks list.
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The FDA finalized guidance for industry, “Competitive Generic Therapies,” which describes the process that generic drug applicants should follow to request designation of a drug as a CGT and the criteria for that designation.
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The FDA has issued a final guidance for industry, Evaluation of Bulk Drug Substances Nominated for Use in Compounding Under Section 503B of the Federal Food, Drug, and Cosmetic Act.
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Friday, September 21, 2018
The FDA is finalizing two guidance documents and making available one draft guidance to help ensure that prescription drug products are identified and traced properly as they move through the supply chain in compliance with federal law.
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Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration.
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Monday, February 01, 2016
Eagle Pharmaceuticals has announced that the U.S. Food and Drug Administration ("FDA") has granted Fast Track designation to its RYANODEX® (dantrolene sodium for injectable suspension) for the treatment of exertional heat stroke (“EHS”), an ...
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Tuesday, October 06, 2015
Bristol-Myers Squibb has announced that the FDA has accepted for filing and review three supplemental New Drug Applications (sNDAs) for Daklinza(daclatasvir), an NS5A replication complex inhibitor, for use with sofosbuvir with or without ribavirin.
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Glenmark has received a CRL from the FDA for Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray.
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Wednesday, September 04, 2019
The FDA has issued a Complete Response Letter for the New Drug Application for Insulin Glargine filed by the company’s partner, Mylan.
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The FDA took two additional significant diagnostic actions during the coronavirus outbreak by issuing EUAs to: Hologic and LabCorp.
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