| 10/23/2017 | Ironmag Labs | Los Angeles District Office | Unapproved New Drugs/Misbranded | Not Issued * |
Human Medications, Human Drugs, Animal Medications, Animal Drugs, Pharmacy law, Pharmaceutical law, Compounding law, Sterile and Non Sterile Compounding 797 Compliance, Veterinary law, Veterinary Compounding Law; Health Care; Awareness of all Types of Compounding Issues; Pharmacy Benefit Managers (PBMs), Outsourcing Facilities Food and Drug Administration and Compliance Issues
Tuesday, October 31, 2017
Do Biosimilars Require Clinical Trials?
Applied Clinical Trials Online (press release) (blog)-Oct 30, 2017
FDA has mapped out a development pathway for biosimilars that relies primarily on structural analysis and preclinical and clinical pharmacology studies to ...
Drugmaker set to profit from an opioid it said was unsafe
WGNO-Oct 30, 2017
Endo contended that the new Opana ER and its hard coating deterred abuse, but this summer, the FDA disagreed. In June, the regulatory agency concluded that ...
Endo to receive royalties from generic opioid it once called 'unsafe ...
Becker's Hospital Review-21 hours ago
Becker's Hospital Review-21 hours ago
Par Pharma Suit Tests FDA's Drug Pricing Pushback
Par Pharma Suit Tests FDA's Drug Pricing Pushback
Law360-14 hours ago
It accuses the FDA of creating an "unlawful regime" that will allow compounders to churn out huge quantities of blood-pressure drug vasopressin, despite Par ...
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