The FDA stated that the proposed revision to the maximum daily dosage appeared reasonable and that it was expected that the high-exposure DSUVIA patient data combined with the high-exposure Zalviso patient data may be sufficient to support safety at maximal dosing in the DSUVIA NDA resubmission
Biopharmaceutical company DURECT Corporation (Nasdaq:DRRX) reported on Wednesday the resubmission
of the New Drug Application (NDA) for REMOXY ER to the US Food and Drug Administration (FDA) for the treatment of severe pain enough to require daily, around-the-clock opioid treatment.
The questions raised by the FDA, which triggered the current resubmission
, primarily related to third party chemistry, manufacturing and controls, and the packaging and labeling of the product.
No additional clinical trials have been scheduled, and resubmission
will take place as soon as the additional documentation is prepared.
Further, the US Food and Drug Administration recently provided clear feedback related to the resubmission
of the new drug application for Scilex's lead product candidate, ZTlido (lidocaine patch 1.
The CFPB said it opened a 60-day comment period to help determine if the changes to its Home Mortgage Disclosure Act Resubmission
Guidelines are appropriate for the HMDA data submitted as a result of recent Regulation C changes.
The minister informed me her Department has requested the resubmission
of some reports that have been withdrawn from her Department so they can be considered.
Kelly King, CEO of the bank, said, 'In light of several factors, we approached the resubmission
conservatively and did not request a further increase in capital deployment at this time.
16 -- (BNA) Minister of Justice, Islamic Affairs and Endowments Shaikh Khalid bin Ali Al Khalifa endorsed the House of Representatives' decision regarding resubmission
of abill of law pertaining to proposed constitutional amendments on the Kingdom of Bahrain's Constitution and its Explanatory Notes to the House of Representatives for further studying and discussion.
New and Lapsed * Applicants $1500 Resubmission
Fee ** $50.
Calls have been heard chiefly from the LDP for resubmission
of a no-confidence motion against Kan's Cabinet although it is customary to introduce such a motion only once during one Diet session.
In light of the resubmission
of plans, I am again raising these concerns with the UK and Welsh Governments and calling for a Moratorium on shale extraction until safety concerns have been fully explored.