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Drug shortages continue to plague the U.S. healthcare system — a longstanding problem exacerbated by COVID-19-related trade interruptions, natural disasters, and ever-changing political landscapes. Read More
Persisting first through an FDA complete response letter (CRL), and then through a denial of a formal dispute resolution request, Akebia Pharmaceuticals is now counting on Japanese postmarketing safety data to get vadadustat, its chronic kidney disease (CKD) anemia drug, over the finish line in the U.S. Read More
The FDA published multiple guidances on Friday to help sponsors conduct drug-drug interaction studies for therapeutic proteins, develop drugs for treating bladder pain syndrome, nonclinical evaluation of drug immunotoxic potential and request feedback from agency officials on device submissions under the Q-Submission program. Read More
Over the past week, the FDA issued a proposed rule on Medication Guides and draft guidance on developing drugs for preventive treatment of migraines. Read More
The U.S. Supreme Court on Thursday sent back to a lower court two cases involving a pair of supermarkets accused of overcharging the federal government for prescription drugs in violation of the False Claims Act. Read More
Medicare will pay for treatment with any antiamyloid antibody that is fully approved by the FDA and administered as part of a national registry run by CMS, according to the agency. Read More
Expanding on the clinical development of migraine drugs, the FDA has published a new draft guidance on development of drugs to prevent migraine to complement its current guidance on developing drugs to treat migraine. Read More
FDA investigators handed Novartis Farma SpA a Form 483 after finding documents missing information about equipment calibration, verification testing and software deviations. Read More
Face-to-face FDA meetings may have a hybrid component beginning June 12, focusing on “having only core participants with a primary speaking role in person while others join virtually” to avoid overcrowding of conference rooms as FDA staff return to on-site work. Read More