Drugs
FDA has announced availability of four guidances issued by the International Council for Harmonization. They are: * Good Clinical Practice: Integrated Addendum – amends a previous guidance, Good Clinical Practice: Consolidated Guidance, to encourage implementation of improved and more efficient approaches to clinical trial design, conduct, oversight, recording, and reporting, and also
Devices
FDA has cleared a Lensar 510(k) for the Lensar Laser System with Streamline IV, that expands the platform’s capabilities to include the creation of the corneal pockets and flaps used in ophthalmic procedures treating presbyopia. The enhancement includes a new curved contact patient interface device that enables the
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Petition To Request an Exemption From 100% Identity Testing of Dietary Ingredients: Current Good Manufacturing Practice in Manufacturing, Packaging, Labeling, or Holding Operations for Dietary Supplements — 21 CFR 111.75(a)(1)(ii)” (OMB Control Number 0910-
Devices
FDA has allowed the de novo marketing of IDx LLC.’s IDx-DR, a software program that uses an artificial intelligence (AI) algorithm to analyze images of the eye taken with a retinal camera to detect greater than a mild level of diabetic retinopathy. Diabetic retinopathy occurs when high blood
Drugs
A 2/14-3/20/17 inspection at Tris Pharma, Monmouth Junction, NJ, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 3/26 Warning Letter. Specific violations noted in the letter were * failing to thoroughly investigate any unexplained discrepancy or failure of
FDA Policy/General
Federal Register notice: FDA has announced several product approvals that redeemed a priority review voucher. The agency has determined that the following approved drugs met voucher redemption criteria: Sanofi’s Praluent (alirocumab) approved 7/2015; Sanofi’s Soliqua (insulin glargine and lixisenatide) approved 11/2016; and ViiV Healthcare’s Juluca
Drugs
Patients for Access to Advanced Hemophilia Therapy is asking FDA to hold a public hearing to examine the effects on the nation’s medical system of “commerce-driven, court-ordered, drug access restrictions.” In its 4/8 petition, the group says it is concerned that Baxalta/Shire, as part of
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. South Texas Botanicals Beeville, TX (3/29): FDA inspected the firm 10/2017 and cited the firm’s product labeling that promotes several of its dietary supplements that cause
Drugs
FDA has accepted for priority review a Verastem NDA for duvelisib, a first-in-class oral dual inhibitor of phosphoinositide 3-kinase (PI3K)-delta and PI3K-gamma, indicated for relapsed or refractory chronic lymphocytic leukemia/small lymphocytic lymphoma (CLL/SLL) and accelerated review for treating relapsed or refractory follicular lymphoma.
Devices
FDA has cleared a Varian 510(k) for a new version of its Velocity cancer imaging software which includes Rapidsphere, a module for Y90 Selective Internal Radiation Therapy (SIRT) dosimetry analysis. The company says Rapidsphere allows cancer care teams to better understand tumor response and normal-tissue toxicity for individual
Devices
FDA has cleared a Johnson & Johnson Vision Care 510(k) for the first contact lens to incorporate an additive that automatically darkens the lens when exposed to bright light. The Acuvue Oasys Contact Lenses with Transitions Light Intelligent Technology are indicated for daily use to correct the vision of
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for “Class 2 Special Controls Guidance Document: Labeling for Natural Rubber Latex Condoms — 21 CFR 884.5300” (OMB Control Number 0910-0633). To view the notice, click here.
Drugs
FDA has denied a 11/8/17 Insys Therapeutics petition asking that it decline to approve any ANDA for generic dronabinol oral solution that cites Syndros as the reference-listed drug if it relies on a waiver in lieu of establishing in vivo bioequivalence to Syndros and to require that
Drugs
FDA has published an International Conference on Harmonization addendum, Clinical Investigation of Medicinal Products in the Pediatric Population, to consider regulatory and scientific advances relevant to pediatric populations that have evolved since the 2000 publication of the original guidance. The addendum does not alter the scope of the original guidance
Devices
FDA says that Custom Ultrasonics has completed validation testing of its System 83 Plus automated endoscope reprocessors with specific duodenoscopes and the agency has determined that the validation data demonstrate that the System 83 Plus can effectively achieve high-level disinfection of the Olympus TJF-180V duodenoscope and the Pentax
Drugs
FDA has released the FDA-483 issued following a 3/12-3/20 inspection at Alembic Pharmaceuticals Limited, Gujarat, India, an oral solid dosage drug manufacturer. Specific observations on the form were: * failing to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components
Drugs
FDA has approved a Pacira Pharmaceuticals NDA for Exparel (bupivacaine liposome injectable suspension) for expanded use as an interscalene brachial plexus nerve block to produce post-surgical regional analgesia following shoulder surgery in adults. Previously, Exparel was approved for local administration to provide post-surgical analgesia. Interscalene brachial plexus nerve
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Atopic Dermatitis: Timing of Pediatric Studies During Development of Systemic Drugs.” The document discusses how early in drug development pediatric patients should be incorporated when evaluating systemic drugs for atopic dermatitis. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance on “Pregnant Women: Scientific and Ethical Considerations for Inclusion in Clinical Trials.” The document discusses ethical and scientific issues when considering the inclusion of pregnant women in clinical trials involving drugs and biological products. It is intended to advance scientific
FDA Policy/General
Federal Register notice: FDA is requesting comments concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use of five drug substances Cannabis plant and resin; extracts and tinctures of cannabis; delta- 9-tetrahydrocannabinol (THC); stereoisomers of THC; and cannabidiol. Comments received will
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension related to its regulation on “Prominent and Conspicuous Mark of Manufacturers on Single-Use Devices” (OMB Control Number 0910-0577). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted for OMB approval an information collection extension for its “Guidance for Industry on Postmarketing Adverse Event Reporting for Medical Products and Dietary Supplements During an Influenza Pandemic” (OMB Control Number 0910-0701. To view the notice, click here.