Drugs
FDA commissioner Scott Gottlieb has hinted that more approved opioid products could be withdrawn from the market if the agency determines through post-market information that a product’s risks outweigh its benefits. Last month, the agency asked Endo Pharmaceuticals to remove its Opana ER (oxymorphone hydrochloride) opioid pain medication
Drugs
FDA has agreed to a consent decree of permanent injunction against Medistat RX LLC (Foley, AL), the company’s co-owners, Mark D. Acker and Timothy L. Fickling, and quality manager and pharmacist-in-charge V. Elaine Waller. The court order “prohibits Medistat, its owners and pharmacist-in-charge from
Drugs
FDA has approved an Emmaus Medical NDA for Endari (L-glutamine oral powder) for patients five years and older with sickle cell disease to reduce severe complications associated with the blood disorder. “Endari is the first treatment approved for patients with sickle cell disease in almost 20 years,” CDER Oncology
Drugs
Senator Orrin Hatch (R-UT) has introduced the Orphan Product Extensions Now Accelerating Cures and Treatments Act (OPEN ACT) of 2017. He says it would build on the success of the Orphan Drug Act to provide additional incentives to increase market potential for companies that repurpose previously approved drugs for
Drugs
CDER officials are advocating for more use of master protocols for “precision medicine” trials to evaluate targeted therapies. Writing in a 7/6 online New England Journal of Medicine article, Center director Janet Woodcock and Office of Biostatistics director Lisa LaVange say the move to such protocols is needed because
Drugs
Alexion Pharmaceuticals is reportedly under investigation by the HHS Office of Inspector General (OIG) over its support for charities that aid Medicare patients, already being investigated by the U.S. Attorney’s Office in Massachusetts. Earlier this year, Alexion said it had received a subpoena asking for documents about this.
Drugs
FDA Files Annual Reports on Closed Panel Meetings Federal Register notice: FDA has filed with the Library of Congress annual reports of certain FDA advisory committees that held closed meetings during fiscal year 2016.The annual reports are required by the Federal Advisory Committee Act. To view the notice, click
Drugs
FDA has accepted for review a Sunovion Pharmaceuticals supplemental NDA for the expanded use of Latuda (lurasidone HCl) in children and adolescents (10 to 17 years of age) with major depressive episodes associated with bipolar 1 disorder (bipolar depression) as monotherapy. Latuda is currently indicated in the U.S. for
Drugs
FDA has issued a draft guidance on Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy. The document tells manufacturers and other supply chain stakeholders that although manufacturers are to begin including a product identifier on prescription drug packages and cases 11/27, the agency is delaying
Drugs
FDA has released its plan to eliminate the existing orphan drug designation backlog and ensure timely response to all new designation requests with firm deadlines. An agency news release (contains link to modernization plan) says the plan comes one week after commissioner Scott Gottlieb committed in Senate subcommittee testimony to
Drugs
FDA has cleared a Varian Medical Systems 510(k) for its Halcyon system for cancer treatment. The company says the device is designed to simplify and enhance most aspects of image-guided volumetric intensity modulated radiotherapy. “With its streamlined workflow, the system only requires nine steps from the start to
Drugs
FDA has released the FDA-483 issued following a 6/12-6/16 inspection at Dr. Reddy’s Laboratories, Andhra Pradesh, India. The violation noted on the form involved a finding that testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to
Drugs
FDA has published the FDA-483 issued following a 6/12-6/16 inspection at Lupin Limited, Madhya Pradesh, India. Observations shown in the form were: * failing to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed; * failing to establish control procedures that monitor the
Drugs
FDA has granted Marinus Pharmaceuticals an orphan drug designation for ganaxolone for treating CDKL5 Disorder. The drug is currently being evaluated in a Phase 2 clinical trial in children with CDKL5 Disorder, which affects children at an early age and causes difficult-to-control seizures and neuro-developmental impairment. Ganaxolone,
Drugs
APCO Worldwide says that while the biopharmaceutical industry’s reputation remained stable since last year, there is little reason to believe it will continue in a positive direction without a shift in engagement strategies. The firm’s Return our Reputation study says the central industry vulnerability is a doubt about
Drugs
FDA is publishing a Federal Register notice soliciting comment on a statement of work for assessing the Program for Enhanced Review Transparency and Communication for 351(k) biosimilar applications. The program is part of agency performance commitments under the proposed reauthorization of the Biosimilar User Fee Act for 2018-2022.
Drugs
[Correction *] Starting early next year, FDA will begin encouraging a voluntary quality metrics reporting program to calculate three metrics, according to industry representatives presenting (see slides) at a Drug Information Association (DIA) session in Chicago 6/21. An earlier posting of this report last week erroneously attributed this information to
Drugs
The Clinical Trials Transformation Initiative (CTTI) has released recommendations and tools to provide a pathway for using information gathered from mobile technologies to accelerate development and evaluation of new therapies. The recommendations and tools are designed to help diverse stakeholders identify and develop novel endpoints based on data from mobile
Drugs
FDA has released a draft guidance on “Current Good Manufacturing Practice for Medical Gases.” The agency says the document was mandated under the FDA Safety and Innovation Act to provide additional guidance on GMP regulations to reduce the regulatory compliance burden for the medical gas industry. It is intended to
Drugs
FDA acting chief scientist Luciana Borio has accepted a one-year detail with the National Security Council to assist with medical and biodefense preparedness. CDER Office of Medical Policy acting director Denise Hinton is being reassigned to the permanent position of deputy chief scientist, and she has agreed to serve
Drugs
PharMEDium Services has recalled specific lots of potassium phosphate and succinylcholine chloride due to a lack of sterility assurance. The recall is related to a 6/15-announced Hospira recall because the PharMEDium products were compounded using certain Hospira products. The latest recall notice says that in the event a
Drugs
FDA says it is taking the first two steps under the agency’s Drug Competition Action Plan to increase competition in the market for prescription drugs and facilitate entry of lower-cost alternatives. An agency news release says the actions involve publishing a list of off-patent, off-exclusivity branded