Drugs
Acer Therapeutics has resubmitted its NDA for ACER-001 (sodium phenylbutyrate) for oral suspension for treating patients with urea cycle disorders (UCDs). The resubmission addresses items raised by the agency in a complete response letter issued last month, which identified the company’s third-party contract packaging manufacturer as not
FDA Policy/General
Federal Register notice: FDA is announcing the date that support begins for versions 1.2 and 1.3 of the Clinical Data Interchange Standards Consortium (CDISC) Analysis Data Model Implementation Guide (ADaMIG) and the date that this version update is required in certain submissions. Support for versions 1.2 and
Drugs
Acadia Pharmaceuticals has submitted an NDA for trofinetide for treating Rett syndrome in adults and pediatric patients two years of age and older. The submission is based on data from the pivotal Phase 3 Lavender study evaluating the efficacy and safety of trofinetide versus placebo in 187 girls and young
Drugs
A group of bipartisan lawmakers is urging FDA to do more to help get therapies approved for treating amyotrophic lateral sclerosis (Lou Gehrig’s Disease). Reps. Mike Gallagher (R-WI), Anna G. Eshoo (D-CA), Brett Guthrie (R-KY), Jan Schakowsky (D-IL), Gus Bilirakis (R-FL), Mike Quigley (D-
Drugs
FDA’s alleged foot dragging in recommending updated Covid-19 vaccines last month and in approving the release of new Monkeypox vaccines illustrates the need to reform the agency, according to a 7/18 Forbes article by Pacific Research Institute president Sally Pipes in which she takes issue with what
FDA Policy/General
Senator Richard Burr (R-NC) has introduced a watered-down FDA user fee reauthorization bill that is intended to address Republican concerns over the current user fee package that the Health, Education, Labor and Pensions (HELP) Committee marked up last month. HELP committee ranking member Burr said the new measure
Drugs
FDA has approved a Pfizer supplemental NDA for Xalkori (crizotinib) for adult and pediatric patients with unresectable, recurrent, or refractory inflammatory anaplastic lymphoma kinase (ALK)-positive myofibroblastic tumors (IMT). Approval was based on data from two single-arm, open-label trials that included 14 pediatric patients from trial ADVL0912 (NCT00939770)
Drugs
The Vermont federal court has permanently enjoined a Colchester, VT, compounding pharmacy from distributing drugs unless they are manufactured in compliance with FDA regulations. A federal government complaint alleges that Edge Pharm Inc., and its owners, Marc Chatoff and Kurt Radke, violated agency regulations by manufacturing and distributing adulterated and
Devices
FDA has cleared an Eko 510(k) for its Eko Murmur Analysis Software (EMAS) for detecting and characterizing murmurs found in adults and pediatric patients. The smart stethoscope can “identify and differentiate between innocent and structural heart murmurs indicative of valvular heart disease,” the company says. Valvular heart disease is
Devices
An FDA safety communication is advising that testing for monkeypox virus should use swab samples taken directly from a lesion (rash or growth). “The FDA is not aware of clinical data supporting the use of other sample types, such as blood or saliva, for monkeypox virus testing,” the safety notice
FDA Policy/General
Federal Register notice: FDA is revoking the emergency use authorization issued to ScienCell Research Laboratories for its ScienCell SARS–CoV–2 Coronavirus Real-time RT–PCR Detection Kit because the company told the agency that the device is no longer being distributed. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Instructions for Use—Patient Labeling for Human Prescription Drug and Biological Products — Content and Format.” The document provides recommendations for developing the content and format of an Instructions for Use document for prescription drug and biological products, as well
Drugs
FDA has approved a Provepharm NDA for Bludigo (indigotindisulfonate sodium), a diagnostic dye indicated for use as a visualization aid in the cystoscopic assessment of the integrity of the ureters in adults who’ve undergone urological and gynecological open, robotic or endoscopic surgical procedures. The company says iatrogenic damage of
FDA Policy/General
Federal Register proposed rule: FDA is proposing to revoke its methods of analysis regulation (21 CFR 2.19) that describes policy to use certain methods of analysis for FDA enforcement programs when the method is not prescribed in a regulation. The agency believes that the regulation is unnecessary. Absent specifying
FDA Policy/General
The House Energy and Commerce Committee leadership is urging the Senate to “urgently” reauthorize FDA’s user fee programs. “Unless the Senate acts urgently to meet its deadline, FDA will be forced to issue reduction-in-force notices and furlough thousands of workers who ensure the safety and efficacy of
Drugs
Pfizer’s Hospira unit is recalling one lot of propofol injectable emulsion (containing benzyl alcohol) due to a visible particulate observed in a single vial during annual examination of retained samples. An FDA notice says patients receiving the affected product are at risk of experiencing life-threatening adverse clinical effects
Devices
FDA is requesting input on patient safety, including best practices to promote patient safety, education, and competency, associated with medical software functions that are excluded from the medical device definition by the 21st Century Cures Act. An agency notice says the input will help it develop a report on the
Drugs
FDA has published a guidance, Instructions for Use — Patient Labeling for Human Prescription Drug and Biological Products — Content and Format, with recommendations for developing the content and format of a patient instructions for use (IFU) document for human prescription drugs and biological products, as well as drug-led or biologic-
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Genentech’s Enspryng (satralizumab-mwge), indicated for treating neuromyelitis optica spectrum disorder in adult patients who are anti-aquaporin-4 antibody positive. The regulatory review period is 2,495 days, of which 2,128 days
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for GlaxoSmithKline’s Blenrep (belantamab mafodotin-blmf), indicated for treating adult patients with relapsed or refractory multiple myeloma who have received at least four prior therapies including an anti-CD38 monoclonal antibody, a proteasome inhibitor, and
Drugs
Summit Therapeutics says it will consider at least one additional clinical trial (XXX SINGULAR XXX) of its ridinilazole, an investigational treatment for C. Diff infection, as discussed at a recent Type C meeting with FDA officials. The company says the meeting focused on data from the Ri-CoDiFy Phase 3
Drugs
Teva is asking the Supreme Court to hear its appeal of a U.S. Court of Appeals for the Federal Circuit decision in a case involving a so-called “skinny label” for a generic form of the heart drug Coreg (carvedilol). The Teva filing says the question it wants the