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Federal Register Notice: FDA releases a draft guidance: Safety Assessment for IND Safety Reporting.[ Price : $8.95]
FDA approves an ANI Pharmaceuticals ANDA for polyethylene glycol 3350 powder for oral solution, 17mg per scoopful, a generic copy ...[ Price : $8.95]
Catalyst Pharmaceuticals completes a rolling NDA submission for Firdapse (amifampridine phosphate), indicated for treating Lambert...[ Price : $8.95]
Consultant Jon Speer cautions medical device companies not to ignore quality management, design control, and risk management when ...[ Price : $8.95]
Stakeholders praise and criticize FDA for its approach to creating a CDRH patient engagement advisory committee.[ Price : $8.95]
Attorney Alison Nadel says the federal government says that its recoveries from False Claims Act cases have exceeded $3.5 billion ...[ Price : $8.95]
Qualitest Pharmaceuticals agrees to pay $39 million to the federal and several state governments to resolve civil fraud claims ari...[ Price : $8.95]
An Oregon appeals court says the states suit against Johnson & Johnson over its silent recall of defective Motrin should have gone...