Stakeholders provide comments on and seek changes in FDA draft guidances on communication of regulated product information that is consistent with the...
FDA clears a Cardiac Insight 510(k) for its wearable electrocardiogram sensor, Cardea Solo.
Pfizer says it has received grand jury subpoenas relating to a Justice Department probe of three companies that are the sole source for intravenous sa...
Three CDER staffers say that using a target product profile can speed regulatory review times.
FDA concludes a 4/10-18 inspection at Aurobindo Pharmas formulations manufacturing facility in Hyderabad, India that resulted in a six-item Form-483.
Attorney Jennifer Thomas says the federal government opposes an appeal by the Decoster brothers of their three-month jail term for responsible corpora...
Egalet Corp. files a prior approval supplement for Oxaydo (oxycodone HCl, USP) tablets that seeks to market 10 mg and 15 mg dosage strengths for use i...
FDA clears a Life Spine 510(k) for the Plateau-C Ti Cervical Spacer System.