[ Price : $8.95]
FDA grants HighTide Therapeutics a fast track designation for its investigational new drug, HTD1801, for treating patients with pr...[ Price : $8.95]
CDRH chief medical officer William Maisel reaffirms the agencys intention to modernize its Quality System regulation for medical d...[ Price : $8.95]
FDA approves an Obalon Therapeutics PMA supplement for the Obalon Touch Inflation System for use in inflating the Obalon Balloon, ...[ Price : $8.95]
FDA commissioner Scott Gottlieb explains the need for a new Center of Excellence for Digital Health.[ Price : $8.95]
FDA solicits comments on a draft guidance to update and clarify the Special 510(k) program for some medical devices.[ Price : $8.95]
FDA announces new and expanded research efforts into compounded drugs.[ Price : $8.95]
Federal Register notice: FDA reopens the comment period related to two draft guidance documents on coronary drug-eluting stents.[ Price : $8.95]
Federal Register notice: FDA withdraws approval of seven ANDAs from multiple applicants after they notified the agency in writing ...