FDA Policy/General
The CDER Office of Prescription Drug Promotion is proposing research to determine whether consumers face challenges when multiple indications are promoted in a single direct-to-consumer TV ad. A Federal Register notice says the study also will explore whether the similarity of the indications affects participants’ likelihood to recall
FDA Policy/General
Federal Register notice: FDA has announced a virtual public meeting entitled “Generic Drug User Fee Amendments (GDUFA) of 2017.” New legislation is required by 10/2022 for FDA to continue to collect generic drug user fees for future fiscal years. The meeting is intended to obtain public input on the
FDA Policy/General
Federal Register notice: FDA has made available guidance documents related to the Covid–19 public health emergency. The documents have been implemented without prior comment, but they remain open for comments under the agency’s good guidance practices. To view the notice, click here.
Drugs
FDA has sent Curativa Bay (Clearwater, FL) a Warning Letter after reviewing the company’s Web site and citing its Advanced Hypochlorous Skin Spray over misleading claims that the product is safe/effective for treating Covid-19. The company claims that applying the skin spray around the face and eyes
Drugs
FDA has approved a Chiasma NDA for Mycapssa (octreotide) capsules for long-term maintenance treatment in acromegaly patients who have responded to and tolerated treatment with octreotide or lanreotide. Acromegaly is a rare chronic disease often caused by a benign pituitary tumor and characterized by excess production of growth hormone
Devices
FDA has posted a final guidance entitled “Review and Update of Device Establishment Inspection Processes and Standards.” The guidance complies with section 702(b)(2) of the FDA Reauthorization Act of 2017, which directs it to issue guidance that specifies how the agency will implement uniform processes and standards that
FDA Policy/General
In observance of the Fourth of July (Independence Day) holiday in the U.S., the news operations of FDA Webview are closed until Monday, July 6. The next overnight email news bulletin from this site will be issued that evening.
Drugs
A new FDA post discusses research by CDER statisticians who developed innovative and more efficient ways to evaluate transdermal and topical delivery systems (collectively called TDS). Instead of evaluating similarity of adhesion between test and reference scores as the ratio of means (ROM) adhesion scores, CDER statisticians settled for a
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Community-Acquired Bacterial Pneumonia (CABP): Developing Drugs for Treatment.” The document clarifies the time to assess the primary efficacy endpoint (Day 4), updates to the CABP trial population based on the Pneumonia Patient Outcomes Research Team scores, evaluation of
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Hospital-Acquired Bacterial Pneumonia and Ventilator-Associated Bacterial Pneumonia: Developing Drugs for Treatment.” The document includes updates to the intended trial population, randomization, prior antibacterial drug therapy, and analysis populations. To view the notice, click here.
Drugs
The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on interpreting sameness of gene therapy products under the orphan drug regulations is helpful and contains a framework drafted in a way that supports the development of innovative gene therapy products. The BIO comment letter says the association appreciates the
Drugs
The Association for Accessible Medicines and Teva have raised identical questions and issues about an FDA draft guidance on technical considerations for demonstrating the reliability of emergency-use injectors submitted under a BLA, NDA, or ANDA. The company and association raise these issues: * FDA needs to come to a reasonable
Drugs
Over the last seven years, FDA has been working to get a handle on its vast data resources to achieve a 360-degree view of the drug development lifecycle. How the agency approached the challenge was recently discussed by CDER Office of Strategic Programs supervisor and computer scientist Shanthi Vigneshwaran
Devices
Chengdu Ai Qin E-commerce Co. has recalled its colored contact lenses after FDA notified the firm that they were distributed without agency clearance and may pose a threat to health. The devices were sold through the Web site www.ttdeye.com and shipped directly to customers. The recalled products
Drugs
FDA has scheduled a 7/21 virtual public meeting to obtain input on the reauthorization of the Generic Drug User Fee Amendments of 2012 for FY 2023-2027 (GDUFA 3). The amendments authorize FDA to collect user fees to support the review of generic human drug applications. A meeting notice
FDA Policy/General
A 7/22-8/9/19 FDA inspection at Rapid Equine Solutions, Aston, PA, found that animal drug products compounded by the firm are adulterated and misbranded. A 6/12 Warning Letter says the agency inspection followed the death of three horses that were given an animal drug compounded by
Devices
FDA has cleared a Ekso Bionics 501(k) for the EksoNR robotic exoskeleton for use with patients with acquired brain injury (ABI). The device was previously cleared for stroke and spinal cord injury rehabilitation in 2016. The company says that ABI is the broadest category of brain injury and comprises
Drugs
An online post explains how FDA is building on its more than a decade of experience in working with the European Commission and its European Medicines Agency (EMA) to collaborate on several scientific and regulatory fronts as part of the Covid-19 response. The paper says that what has helped
Devices
FDA has approved a Medtronic PMA for the Percept PC Deep Brain Stimulation (DBS) system for treating patients with neurologic disorders associated with Parkinson's disease, essential tremor, dystonia, epilepsy or obsessive-compulsive disorder. DBS is an individualized therapy delivered from a small pacemaker-like device, placed under the
Biologics
Public Citizen says the U.S. government may jointly own Moderna’s mRNA-1273, a leading Covid-19 vaccine candidate, and should use that ownership to make the vaccine affordable to all in plentiful supply if it is demonstrated to be safe and effective. A report issued by the advocacy
Drugs
FDA has approved Merck’s Keytruda (pembrolizumab) as monotherapy for treating patients with recurrent or metastatic cutaneous squamous cell carcinoma (cSCC) that is not curable by surgery or radiation. Approval was based on data from the Phase 2 KEYNOTE-629 trial that demonstrated Keytruda’s meaningful efficacy and durability of
Devices
FDA has qualified the Insulin Dosing Systems Perceptions. Ideas, Reflections, and Expectations (INSPIRE) questionnaires through the Medical Device Development Tools (MDDT) program. Once qualified, an agency notice says, the INSPIRE questionnaires can be used to qualitatively assess the impact of automated insulin dosing (AID) systems to manage Type 1 diabetes