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Top Stories
The companies plan to combine their preclinical candidates to develop small-molecule inhibitors against multiple drug targets.
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FDA continued to demonstrate its flexibility and support for biomedical innovation by approving a number of important new therapies.
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Industry News
The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.
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Aurobindo Pharma USA, Inc. voluntarily recalled Mirtazapine Tablets due to an error on the label that listed the incorrect strength.
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Supplier News
Through the acquisition, Johnson & Johnson will gain access to Taris’ lead clinical-stage product, TAR-200.
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The new site can manufacture oligonucleotide APIs at large scale.
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More Supplier News
| Bio/Pharma News
Boehringer Ingelheim Biopharmaceuticals China is the first company to apply the adopted Marketing Authorization Holder system within the revised Chinese Drug Administration Law through its partnership with BeiGene for its monoclonal antibody, tislelizumab.
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The sNDA was accepted after positive results from a Phase III trial were published in September 2019 that concluded the drug reduced the incidence of cardiovascular death or the worsening of heart failure versus placebo.
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Regulatory News
The agency sent a warning letter to Henan Kangdi Medical Devices Co. Ltd after an inspection found CGMP violations that included a variety of failures of the company’s quality unit.
/ read more /
FDA sent a warning letter to GPT Pharmaceuticals Pvt. Ltd. after inspectors found CGMP violations that included equipment that was not properly maintained.
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Featured Topics |
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QUALITY SYSTEMS
Investigating deviations of combination products needs to accommodate both the drug and device components, says Susan J. Schniepp, executive vice-president of post-approval pharma and distinguished fellow, Regulatory Compliance Associates.
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REGULATORY WATCH
Regulators are facing huge challenges on how to deal with the digitalization transformation occurring in the healthcare and pharmaceutical sectors.
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MANUFACTURING
At-line NIR measurements can replace a laboratory HPLC measurement for API content in oral solid-dosage drug manufacturing.
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OUTSOURCING
With an increased focus on the supply chain security of non-cGMP intermediates, companies need to re-emphasize upstream manufacturing.
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January 15–16, 2020
January 20–21, 2020
February 5–6, 2020
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In Pharmaceutical Technology's ongoing Pharmacopoeia Compliance Series, experts explain the revision process for global and national pharmacopoeias, best practices for monitoring changes, and how to participate in revisions. Other features include FDA warning letters, building a quality culture, and essentials for DOE and QRM.
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