Drugs
HHS secretary Alex Azar says the administration is changing a key element in its plan to lower drug prices because President Donald Trump wants the plan to go further than originally announced. The Hill reports that Azar spoke at an Axios event and said that under the original proposal some
Drugs
FDA has been making less use of human drug advisory committees, scheduling only 23 meetings this year, according to an analysis by Eye on FDA. There are 31 total advisory committees, with 18 of them relating to human drugs. The report says that 19 of the 23 meetings were related
Drugs
The Stericycle Expert Solutions First Quarter recall index says drug recalls decreased 6.5% to 72, the second-lowest number in the past 12 quarters. However, recalled units stayed high at just over 22 million. “The average number of recalls per quarter so far in 2019 is trending to be
Drugs
Braeburn says that in light of the FDA decision to grant its April petition requesting revocation of Indivior’s orphan designation for Sublocade (buprenorphine extended-release) injection, Braeburn’s Brixadi (buprenorphine) weekly and monthly extended-release injection to treat opioid use disorder can be marketed as of 12/1/20.
Devices
FDA has issued a guidance, Process to Request a Review of FDA’s Decision Not to Issue Certain Export Certificates for Devices, to specify the process afforded to persons denied a Certificate to Foreign Government (CFG) for a medical device. The document describes the information CDRH and CBER, in collaboration
FDA Policy/General
In a Securities and Exchange Commission (SEC) case that could affect FDA and several other government agencies that routinely seek disgorgement, the Supreme Court has agreed to consider the question of whether the SEC has the legal authority to seek disgorgement. The case follows a unanimous high court 6/2017
Drugs
GlaxoSmithKline says next year it will seek approval for Nucala (mepolizumab) for treating patients living with Hypereosinophilic Syndrome (HES) based on just-announced positive results from a pivotal study. The Phase 3 study met its primary endpoint — demonstrating a statistically significant result with 50% fewer patients experiencing a HES flare
FDA Policy/General
Federal Register notice: FDA is announcing a 12/6 public workshop on incorporating clinical outcome assessments into endpoints for regulatory decision making. The workshop’s discussions will be used in developing patient-focused drug development guidance as required by the 21st Century Cures Act and as part of commitments agreed
Devices
FDA has launched Web pages on devices used to treat temporomandibular disorders (TMD), including temporomandibular joint (TMJ) implants. The pages (1) provide information on FDA-approved devices that are used for TMD, including TMJ implants; (2) share information for patients considering TMJ implants; and (3) present postmarket surveillance study information,
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications — 21 CFR Part 3” (OMB Control Number 0910-0523). Agency regulations permit it to determine the organizational component within FDA assigned to have primary jurisdiction for
Drugs
A 5/27-6/5 FDA inspection at Mylan Laboratories’ Unit 8, Andhra Pradesh, India, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). An 11/5 Warning Letter says specific violations were: * failing to have adequate written procedures for the receipt, identification, and
Drugs
A 4/22-5/3 FDA inspection at Cadila Healthcare, Ahmedabad, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 10/29 Warning Letter lists the specific violations as: * failing to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or
Devices
Becton Dickinson (BD) has submitted a PMA supplement for an expanded version of its BD Onclarity HPV Assay. The device detects 14 types of high-risk human papillomavirus (HPV) from specimens collected for cervical cancer screening in the BD SurePath Collection Vial. The submission includes data collected during a three-
Devices
FDA has approved a Hologic PMA for its 3DQuorum Imaging Technology for use with the company’s Clarity HD high resolution imaging technology to reduce tomosynthesis image volume for radiologists. The 3DQuorum technology uses Hologic’s Genius Artificial Intelligence-powered analytics to reconstruct high-resolution 3D data to produce 6
Devices
Worried about device shortages that could occur from recent closures due to environmental concerns at facilities that use ethylene oxide (EtO) to sterilize medical devices, FDA convened an advisory committee last week to discuss options and alternative sterilization methods. Members of FDA’s General Hospital and Personal Use Devices Panel
Devices
The International Medical Device Regulators Forum (IMDRF) has published three clinical final documents. The first, “Clinical Evidence—Key Definitions and Concepts,” is intended to (1) introduce the concepts of clinical evaluation and clinical evidence; (2) examine the relationship between clinical investigation, clinical data, clinical evaluation, and clinical evidence; and (3)
Drugs
An FDA briefing paper released in advance of the 11/14 Endocrinologic and Metabolic Diseases Advisory Committee discussion of Amarin’s Vascepa (icosapent ethyl) for an indication to reduce the risk of cardiovascular events as an adjunct to statin therapy in adults with elevated triglycerides and other cardiovascular disease risk
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. MSM Nutraceuticals, Phoenix, AZ (10/24): FDA inspected the firm in May and cited significant GMP violations for finished pharmaceuticals. For example, MSM failed to perform, for each batch
Drugs
FDA principal deputy commissioner for policy Lloyd Schiller told the Council for Responsible Nutrition 11/7 that FDA is looking at possible changes to law that would enable the agency to keep pace with changes in the dietary supplement market that has grown significantly in the last 25 years under
Drugs
FDA has placed on clinical hold the Solid Biosciences IGNITE DMD Phase 1/2 study of the company’s SGT-001 under investigation to treat Duchenne muscular dystrophy. The company says that to date six patients have been dosed with SGT-001. It reports that the third patient experienced a
Drugs
FDA has granted F2G Ltd. a breakthrough therapy designation for olorofim for treating invasive mold infections in patients with limited or no treatment options, including aspergillosis refractory or intolerant to currently available therapy, and infections due to Lomentospora prolificans, Scedosporium, and Scopulariopsis species. The company says that olorofim is the
Drugs
FDA has issued Lipocine a complete response letter on its NDA for Tlando, an oral testosterone product candidate for hormone replacement therapy in adult males for conditions associated with hypogonadism. The letter said Lipocine’s drug efficacy trial did not meet the three secondary endpoints for maximal testosterone concentrations (Cmax)