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Consumer Health – USA/UK/Asia/ROW Reg…
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Outbreak Investigation of Listeria monocytogenes: Frozen Supplemental Shakes
The FDA and …

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USA
Guidance on Institutional Review Board (IRB) Written Procedures
The FDA and HHS OHRP hav…

Pharma/Biotech – USA, Europe, Asia an…
USA
FDA Approves First Rapid-Acting Insulin Biosimilar Product for Treatment of Diabetes
The …

Expanded OTC Approvals and Market Pro…
| OTC
The Over-the-Counter (OTC) drug market has undergone significant evolution since the early 2000s. Wit…

Medical Devices – USA, Europe, Asia a…
USA
Guidance on Premarket Approval Application and Humanitarian Device Exemption Modular Review …

Pharma/Biotech – USA, Europe, Asia an…
USA
FDA Approves Novel Non-Opioid Treatment for Moderate to Severe Acute Pain
The U.S. Food a…
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