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Susan Haigney is managing editor of BioPharm International, susan.haigney@ubm.com.
May 18, 2023
The agency found insanity conditions and CGMP violations at Pharmedica USA, LLC’s Phoenix facility during an inspection.
The two draft guidance documents provide recommendations for the approval of pediatric drugs, biologics, and vaccines under the Pediatric Research Equity Act and the Best Pharmaceuticals for Children Act.
May 17, 2023
The agency’s safety committee is reviewing hydroxyprogesterone medicines and issuing a reminder on safety issues regarding fluoroquinolone antibiotics.
The agency has published guidance on good practices for securing the supply of medicines.
The report outlines highlights from the agency’s medicines evaluations and milestones for 2022.
May 10, 2023
EMA and European regulators are lifting their COVID-19 business continuity measures as the pandemic’s peak ends.