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.
Tuesday, January 26, 2021
The FDA has issued a guidance to notify drug manufacturers, including repackers, relabelers, alcohol suppliers and compounders, of FDA’s policy on testing of alcohol or isopropyl alcohol for methanol prior to using the ingredient in drugs.
read more
The FDA issued a guidance for industry, investigators and institutional review boards conducting clinical trials during the coronavirus (COVID-19) pandemic.
read more
ChromaCode announced that the FDA has granted EUA of ChromaCode's HDPCR™ SARS-CoV-2 Real-Time PCR Assay.
read more
The FDA issued an EUA for the third vaccine for the prevention of COVID-19.
read more
Wednesday, February 05, 2020
The FDA issued an emergency use authorization to enable emergency use of the CDC 2019-nCoV Real-Time RT-PCR Diagnostic Panel.
read more
The FDA has issued a draft guidance for industry, “Duchenne Muscular Dystrophy and Related Dystrophinopathies: Developing Drugs for Treatment,” to assist drug companies in the clinical development of drugs for the treatment of X-linked Duchenne ...
read more
The FDA took two additional significant diagnostic actions during the coronavirus outbreak by issuing EUAs to: Hologic and LabCorp.
read more
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.
read more
Glenmark has received a CRL from the FDA for Ryaltris™ (olopatadine hydrochloride [665 mcg] and mometasone furoate [25 mcg]), Nasal Spray.
read more
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.
read more
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 ...
read more
Protecting the health and safety of our staff and their families is of paramount concern to the U.S. Food and Drug Administration.
read more
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.
read more
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.
read more
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.
read more