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FDA warns Canadas Signa SA de CV about CGMP violations at its Toluca, Mexico, API manufacturing facility.[ Price : $8.95]
FDA warns Centurion Medical Products about manufacturing and distributing unapproved medical device/drug combination sterile conve...[ Price : $8.95]
Federal Register notice: FDA announces an 8/11 public meeting entitled Independent Third-Party Assessment of IND FDA-Sponsor Commu...[ Price : $8.95]
Federal Register notice: FDA announces an 8/13 Oncologic Drugs Advisory Committee meeting to review a Mesoblast BLA for Remestemce...[ Price : $8.95]
FDA places a Pieris Pharmaceuticals Phase 1 study of cancer drug PRS-343 on partial clinical hold while the company conducts an ad...[ Price : $8.95]
Federal Register notice: FDA withdraws approval of 10 ANDAs from multiple applicants after they notified the agency that the drug ...[ Price : $8.95]
Federal Register notice: FDA makes available a draft guidance entitled Appeal Options Available to Mammography Facilities Concerni...[ Price : $8.95]
FDA issues a draft guidance on quality considerations for clinical research related to developing drugs containing cannabis or can...