Federal Register notice: FDA issues a priority review voucher to Orchard Therapeutics for its rare pediatric disease drug approval for Lenmeldy (atida...
Federal Register notice: FDA sends to OMB an information collection extension entitled Expedited Programs for Serious Conditions Drugs and Biologics....
CDER Office of Medical Policy regulatory counsel Christopher Diamant explains why the new Patient Medication Information form was developed and how.
Two Polsinelli attorneys say the Supreme Courts refusal to hear an appeal in a labeling case helps manufacturers argue for preemption.
Patient nonprofit group Haystack Project confirms that former FDA principal deputy commissioner Janet Woodcock is playing an advisory role in its drug...
PhRMA gives FDA general and specific comments on a draft guidance on using data monitoring committees in clinical trials.
FDA approves a Genentech NDA for Alecensa (alectinib) for adjuvant treatment following tumor resection for patients with anaplastic lymphoma kinase-po...
FDA releases the form FDA-483 with three observations from an inspection at a Eugia Steriles drug manufacturing facility in Andhra Pradesh, India, the...
