[ Price : $8.95]
A Center for Innovation in Regulatory Science briefing paper stresses Chinas faster drug approvals and the need for sponsors to ma...[ Price : $8.95]
FDA releases 40 cease and desist (untitled) letters to drug companies that the agency said were issued earlier this month when it ...[ Price : $8.95]
FDA posts a draft guidance entitled Erosive Esophagitis: Developing Drugs for Treatment that outlines recommendations for developi...[ Price : $8.95]
FDA releases the form FDA-483 with four observations from an inspection at the Lupin drug manufacturing facility in Madhya Pradesh...[ Price : $8.95]
Becton Dickinson expands its Class 1 recall of its Alaris Pump Module model 8100 to include 15 additional infusion sets, citing po...[ Price : $8.95]
FDAs ongoing crack down on drug direct-to-consumer promotional activities results in three just-released Warning Letters to Eli Li...[ Price : $8.95]
FDA approves a Krystal Biotech supplemental BLA for a label expansion on its gene therapy Vyjuvek (beremagene geperpavec-svdt), ad...[ Price : $8.95]
Dexcom recalls (Class 1 device correction) its Dexcom G7 App and Dexcom ONE+ App which contain a software design error.