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| Register by 17 July to Save up to 20% | The PDA/FDA Joint Regulatory Conference 2024, the only FDA co-sponsored pharmaceutical CGMP conference, is taking place 9 to 11 September in Washington, D.C. Now in its 33rd year, the conference will offer a comprehensive agenda with substantive technical sessions and practical case studies that provide insight into the effective application of Current Good Manufacturing Practice (CGMP). |
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By Susan Shockey, Clarkston Consulting | The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3. |
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By Tim Sandle, Ph.D. | The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31. |
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By Gunjan Bagla, Amritt Inc. | Startups and Big Pharma companies alike are considering India as an alternative to working with China. Is it safe to do business with India? Let's do a deep dive, with insights from American and Indian attorneys. |
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| Trends In Combination Products | Article | By Fran DeGrazio, West Pharmaceutical Services, Inc. | As demand grows for patient-centric drug delivery via self-administration, combination products are on the rise. Explore three major regulatory themes to consider when producing combination products. |
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