Drugs
FDA has approved an Osmotica Pharmaceutical NDA for Osmolex ER (amantadine extended release tablets) for treating Parkinson’s disease and drug-induced extrapyramidal reactions in adult patients. Extrapyramidal symptoms (movement disorders) are known side effects of many common medications. The drug’s labeling says it is contraindicated in patients with
Drugs
CDER Office of Generic Drugs (OGD) director Kathleen Uhl says that during GDUFA 1 her Office of Research and Standards “built an extensive research portfolio to support development of new methodologies and tools to help establish equivalence standards.” In a report, Uhl says that between 2013 and 2017 OGD awarded
Drugs
AllTrials says its online clinical trial tracking tool will begin flagging clinical trials that have reached the 13-month FDA Amendments Act of 2007 (FDAAA 2007) limit without posting trial results and the fines those companies should be paying. In an open letter to FDA commissioner Scott Gottlieb, AllTrials says
FDA Policy/General
Public Meeting on Pediatric Device Development Federal Register notice: FDA announces an 8/13-14 public meeting entitled “Pediatric Medical Device Development.” 02/16/2018 Guide on How to Prepare Combination Product Designation Request Federal Register notice: FDA makes available a guidance entitled “How to Prepare a Pre-Request for
FDA Policy/General
St. Jude Children's Research Hospital has agreed to spend $412 million to develop an advanced research center as part of a $1 billion capital expansion at its St. Jude campus. The center is intended to foster an environment where scientists and clinicians will pursue breakthroughs in hopes of
Drugs
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee has voted 6 to 4 to not recommend approval of a Pacira Pharmaceuticals supplemental NDA for Exparel (bupivacaine liposome injectable suspension) and its use as a nerve block to produce regional analgesia. The six panel members agreed that more research data
FDA Policy/General
Federal Register notice: FDA has announced an 8/13-14 public meeting entitled “Pediatric Medical Device Development” to identify strategies to improve the medical device ecosystem to enhance development and innovation of pediatric devices. Topics for discussion will include ways to improve research infrastructure and research networks to improve the
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “How to Prepare a Pre-Request for Designation (Pre-RFD)” that explains the Office of Combination Product’s Pre-RFD process the type of information needed to obtain a preliminary assessment from the agency. The Pre-RFD process is available
Drugs
FDA has approved AstraZeneca’s Imfinzi (durvalumab) for treating patients with Stage III non-small cell lung cancer whose tumors are not able to be surgically removed and whose cancer has not progressed after treatment with chemotherapy and radiation. This is the first treatment approved for this disease stage to
Drugs
As a means to help bring down rising drug costs, FDA commissioner Scott Gottlieb says he is stepping up pressure against brand drug makers and their tactics to block generic drug market entries. In a 2/15 interview with Kaiser Health News, the agency head expressed his frustration with brand
Devices
Two medical device researchers have outlined in a 2/15 New England Journal of Medicine perspective piece the benefits and pitfalls of FDA relying on real world evidence (RWE) in regulatory decision making. The researchers reflect on a recent guidance on “Use of Real-World Evidence to Support Regulatory Decision-
FDA Policy/General
Federal Register notice: FDA has determined that U.S. Pharmaceutical Holdings’ Lotensin HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, were not withdrawn from sale for reasons of safety or effectiveness. The determination will allow FDA to approve ANDAs referencing the product if all other legal
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER Submissions’’ along with a document called Bioresearch Monitoring Technical Conformance Guide Containing Technical Specifications. The documents describe and provide
FDA Policy/General
Federal Register notice: FDA has announced a 5/10 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss the safety and efficacy of an Akcea Therapeutics NDA for volanesoren solution for subcutaneous injection, indicated as an adjunct to diet for treating patients with familial chylomicronemia syndrome.
Drugs
FDA has published five guidances as part of a broader focus on advancing treatments for neurological disorders that are not adequately addressed by available therapies. Commissioner Scott Gottlieb says (statement includes links to guidances) the documents “provide details on how researchers can best approach drug development for certain neurological conditions
Drugs
FDA has denied a 3/19 petition submitted by Escher Fund for Autism asking it to withdraw approval of 17-alpha hydroxyprogesterone caproate (17-HPC), including Amag Pharmaceuticals’ Makena, as a drug used in pregnancy, pending assessments of potential deleterious effects on the fetal germline. The denial letter says the
FDA Policy/General
Federal Register notice: FDA has announced a 3/7 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Amgen supplemental BLA for Blincyto (blinatumomab) injection for intravenous use, indicated for treating minimal residual disease-positive B-cell precursor acute lymphoblastic leukemia. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Regulatory Classification of Pharmaceutical Co-Crystals.” The document provides NDA/ANDA applicants information on the appropriate regulatory classification of pharmaceutical co-crystal solid-state forms. It also provides information about the data that they should submit to support the appropriate
Drugs
The Critical Path Institute says an FDA discussion document, appendices, and glossary for a guidance on patient-focused drug development “provides useful background information to entities like patient advocacy organizations that may have little experience with drug development and will be useful in that respect.” The institute’s comment letter
FDA Policy/General
Federal Register notice: FDA has classified non-absorbable, hemostatic gauze for temporary internal use into Class 2 (special controls). The action responds to a 2016 de novo classification request by Z-Medica for its D2 Dressing. The agency has identified the generic prescription device as intended to be placed temporarily
Drugs
Writing for Washington Legal Foundation, two Fried, Frank attorneys say the time may be right to look again at constitutionality of the False Claims Act’s (FCA) qui tam (relator or whistleblower) provisions that allow a whistleblower to independently prosecute a False Claims Act case on behalf of the United
Devices
FDA has approved an expanded indication for the Concentric Medical Trevo clot retrieval device to allow treatment of certain stroke patients up to 24 hours after symptom onset, expanding the use to a broader group of patients. An agency news release says the device is cleared for use as an