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, April 13, 2022
Biofrontera Inc. announced that the U.S. Food and Drug Administration (FDA) has approved Biofrontera Pharma’s cGMP laboratory in Leverkusen, Germany, as a contract laboratory for batch control and stability testing of Ameluz® (aminolevulinic acid ...
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Wednesday, April 08, 2020
The FDA approved the first generic of Proventil HFA Metered Dose Inhaler, 90 mcg/Inhalation, for treatment or prevention of bronchospasm.
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Amgen announced the FDA has approved RIABNI, a biosimilar to Rituxan.
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Samsung Bioepis announced the FDA has approved HADLIMA™ (adalimumab-bwwd), a biosimilar referencing HUMIRA® (adalimumab).
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The FDA awarded 15 new clinical trial research grants totaling more than $22 million to boost development of products for patients with rare diseases.
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The FDA has awarded a cooperative agreement grant to the NABP to establish an information-sharing system for drug compounding activities that are primarily overseen by states.
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In response to scammers on the internet selling unproven medical products, the FDA has taken a number of steps to find and stop those selling unapproved products that fraudulently claim to mitigate, prevent, treat, diagnose or cure COVID-19.
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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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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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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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The FDA issued an EUA for the third vaccine for the prevention of COVID-19.
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The FDA has been determining the safest and most appropriate time to resume prioritized domestic inspections of FDA-regulated facilities and other associated activities since we first announced postponement in March.
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Wednesday, August 05, 2020
The FDA proposed to include four bulk drug substances on the list of bulk drug substances that outsourcing facilities may use in drug compounding consistent with section 503B of the Federal Food, Drug & Cosmetic Act.
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The FDA has proposed to include one additional bulk drug substance on the list of bulk drug substances that outsourcing facilities may use in drug compounding consistent with section 503B of the Federal Food, Drug and Cosmetic Act.
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