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Holdings’ Lotensin HCT (benazepril hydrochloride; hydrochlorothiazide) oral tablets, 5 mg and 6.25 mg, were not withdrawn from sale for reasons of safety or effectiveness.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Federal Register notice: FDA has made available a draft guidance entitled “Standardized Format for Electronic Submission of NDA and BLA Content for the Planning of Bioresearch Monitoring (BIMO) Inspections for CDER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
Devices
FDA has authorized marketing of the Banyan Biomarkers Banyan Brain Trauma Indicator, a blood test used to evaluate mild traumatic brain injury (concussion). An agency news release says that most patients with a suspected head injury are examined using a neurological scale (Glasgow Coma Scale) followed by a CT head
Drugs
FDA has accepted for review an Agios Pharmaceuticals NDA for ivosidenib (AG-120) for treating patients with relapsed or refractory acute myeloid leukemia with an isocitrate dehydrogenase 1 mutation. The submission was granted a priority review, with a user fee review action date of 8/21. Ivosidenib is a first-
Devices
FDA has granted Abiomed expanded PMA approval for the Impella 2.5 and Impella CP heart pumps and their use during elective and urgent high risk percutaneous coronary intervention procedures. The approval also eliminates an earlier requirement for depressed ejection fraction in the presence of severe coronary artery disease or
Drugs
Apace Packaging has recalled one lot of shingles therapy acyclovir tablets, USP, 400mg, (NDC# 50268-061-15, lot number 19900) due to a product mix-up. A small number of blister cards containing acyclovir tablets, 400mg, may potentially also include torsemide, 20mg, tablets. “Missing a dose of acyclovir tablets could
FDA Policy/General
Federal Register proposed rule: FDA is proposing to amend its postmarketing safety reporting regulations for approved new animal drugs to require that certain adverse drug experience and product/manufacturing defect reports be submitted in an electronic format. The proposed change would allow FDA to more rapidly review such reports, identify
Drugs
FDA says its 2/7 approval of an ANDA for trientine hydrochloride (Valeant’s Syprine) to treat Wilson disease renders moot an 8/17/17 petition requesting such an approval. The agency response says the petition “asserted that the approval of an ANDA for trientine hydrochloride will make available a
Drugs
Pharmaceutical industry stakeholders are telling FDA about many regulations they believe could be eliminated or modified in the interest of reducing administrative burden and improving efficiency. In a 127-page response, Pharmaceutical Research and Manufacturers of America lists 41 topics under three overriding categories — manufacturer communications and prescription drug labeling,
Drugs
FDA has issued a guidance, Regulatory Classification of Pharmaceutical Co-Crystals, to give applicants planning to submit NDAs and ANDAs information on the appropriate regulatory classification of pharmaceutical co-crystal forms. The guidance includes information about the data that applicants should submit to support the appropriate classification of a co-