Drugs
FDA has approved an AbbVie NDA for Orilissa (elagolix), the first oral gonadotropin-releasing hormone (GnRH) antagonist specifically developed for women with moderate to severe endometriosis pain. Approval is supported by data from two replicate Phase 3 studies involving nearly 1,700 women with moderate to severe endometriosis pain. Clinical
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” The document describes the agency’s current recommendations on this subject where dietary management is a key component
Drugs
FDA has published a draft guidance, Use of Liquids and/or Soft Foods as Vehicles for Drug Administration: General Considerations for Selection and In Vitro Methods for Product Quality Assessments, addressing the approaches recommended for suitability determination of vehicles intended for use with specific drug products. The document provides: * consideration
Drugs
On the same day Public Citizen filed a lawsuit against it, FDA 7/23 partially granted the activist group’s objective: a ban on cesium chloride use in drug compounding sought in a 12/2017 petition. The group’s lawsuit was in response to the agency’s inaction on the
Drugs
FDA has released a draft guidance on “Inborn Errors of Metabolism That Use Dietary Management: Considerations for Optimizing and Standardizing Diet in Clinical Trials for Drug Product Development.” The document describes the current recommendations about how to optimize and standardize dietary management in such trials where dietary management is a
Devices
FDA has cleared a Medi-Lynx Cardiac Monitoring 510(k) for the PocketECG Cardiac Rehabilitation System, a mobile cardiac rehabilitation designed to provide ECG monitoring and automated arrhythmia detection during rehabilitation training. The smartphone-sized device is intended to monitor a patient’s heart rhythm and heart rate during rehabilitation
Drugs
FDA has granted Allergan a fast track designation for AGN-241751, an investigational new treatment for major depressive disorder. AGN-241751 is a novel, orally bioavailable, small molecule N-methyl-D-aspartate receptor modulator that recently entered Phase 2 development, the company says. Allergan acquired AGN-241751 as part of
Drugs
FDA has accepted for review an Aerie Pharmaceuticals 505(b)(2) NDA for Roclatan (netarsudil/latanoprost ophthalmic solution) 0.02%/0.005%, a once-daily eye drop designed to reduce intraocular pressure in patients with glaucoma or ocular hypertension. It is a fixed dose combination of Aerie’s Rhopressa (netarsudil
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that provide product-specific recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
Devices
FDA has cleared a NeuMoDx Molecular 510(k) for its NeuMoDx 288 Molecular System and its NeuMoDx GBS [Group B Streptococcus] Assay. “The fully automated NeuMoDx 288 Molecular System is the first offering in a family of scalable platforms that integrate the entire diagnostic process – from extraction to detection or
FDA Policy/General
DEVICES FDA has cleared an Adaptiiv 510(k) for its 3D Bolus Software for use in creating customized personal medical devices using 3D printing, primarily for use in treating cancer. The software allows practitioners 3D printing of patient-specific uniform thickness bolus, modulated bolus for MERT (modulated electron radiation therapy)
Drugs
FDA has posted 43 product-specific guidances (26 new guidances and 17 revised guidances) that describe the agency’s current thinking and expectations on how to develop generic drug products. The new batch of documents is part of FDA’s strategy to promote generic drug development to address rising drug
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for its “Metered Dose Inhaler and Dry Powder Inhaler Drug Products — Quality Considerations; Draft Guidance for Industry.” Comments can be submitted by 9/18. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is extending the comment period until 10/18 for a guidance entitled “Documenting Electronic Data Files and Statistical Analysis Programs.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Requirements on Content and Format of Labeling for Human Prescription Drug and Biological Products” (OMB Control Number 0910–0572). FDA’s regulations require that the labeling of new and recently approved products contain highlights of prescribing information,
Devices
Bayer has decided to stop marketing its controversial Essure permanent birth control device, effective 12/31. The company’s move follows an April FDA patient safety action, in which the agency issued an order restricting the sale and distribution of Essure (see story). “For women who have received an Essure
Drugs
FDA has approved an Agios Pharmaceuticals NDA for Tibsovo (ivosidenib) tablets for treating adult patients with relapsed or refractory acute myeloid leukemia (AML) who have a specific genetic mutation. This is the first isocitrate dehydrogenase-1 inhibitor approved for use with an FDA-approved companion diagnostic (Abbott’s RealTime IDH1
Drugs
FDA has approved a Pfizer BLA for Nivestym (filgrastim-aafi), a biosimilar product referencing Amgen’s Neupogen, indicated for treating neutropenia. Filgrastim is a short acting granulocyte-colony stimulating factor that increases the body’s production of white blood cells. The BLA submission is supported by similarity data from analytical,
Drugs
FDA has granted Sellas Life Sciences Group a fast track designation for its galinpepimut-S and its use in treating multiple myeloma. The therapy is licensed from Memorial Sloan Kettering Cancer Center and targets the Wilms Tumor 1 protein, which is present in an array of tumor types. The designation
Drugs
FDA commissioner Scott Gottlieb and two top CDER officials say the agency is investing in a multifaceted system of pharmacovigilance, using various tools to mine traditional and new sources of epidemiologic data, assess products’ pharmacologic properties, and evaluate the social contexts in which substances are being used. Writing in the
Drugs
In a break from past practices, FDA commissioner Scott Gottlieb says he is forming a work group to explore policy frameworks that could lead to short-term importation of drugs to help resolve specific drug shortage situations. In a statement, Gottlieb says the group will “consider whether and how the
Drugs
CDER director Janet Woodcock says that an FDA reorganization plan submitted to HHS for approval before going to Congress for concurrence will affect nearly one-third of CDER offices. “The changes within CDER offices will enable us to respond to new priorities more efficiently with a stronger organizational framework and