FDA Policy/General
Federal Register notice: FDA has classified Lynch syndrome test systems into Class 2 (special controls). The action is based on a Ventana Medical Systems de novo classification request for its Ventana MMR IHC Panel. The agency has named the generic device as Lynch syndrome test systems, which are identified as
FDA Policy/General
Federal Register notice: FDA has corrected a 6/21/2017 Federal Register notice that announced the withdrawal of approval of 121 NDAs and 161 ANDAs from multiple applicants. A Baxter Healthcare NDA for Clinolipid 20% (olive oil and soybean oil) USP that was included in the original notice is now
FDA Policy/General
Federal Register notice: FDA has announced a 5/9 public workshop on “Tissue Agnostic Therapies in Oncology: Regulatory Considerations for Orphan Drug Designation.” The workshop is intended to discuss factors the agency should consider when evaluating drugs for orphan designation that treat a tissue-agnostic disease or condition in oncology,
Drugs
A 4/10-4/14/17 FDA inspection at Shanghai Weierya Daily Chemicals Factory, Shanghai, China, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 2/7 Warning Letter. Specific violations cited in the letter were: * failing to have for each batch of
FDA Policy/General
Healthcare and legal researchers at Harvard Medical School and the Georgia State University College of Law say the proposed Regulatory Accountability Act of 2017 “could have potentially disastrous consequences for FDA and other agencies that protect public health.” Writing in the New England Journal of Medicine, the authors say (subscription
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Alchymars ICM SM Private Ltd. Chennai, India (2/16): FDA inspected the firm 9/2017 and cited significant GMP deviations for active pharmaceutical ingredients. For example, the firm failed
Drugs
Akorn says it and Fresenius are using outside consultants to investigate alleged breaches of FDA data integrity requirements relating to product development at Akorn. “To date the company’s investigation has not found any facts that would result in a material impact on Akorn’s operations and the company does
Devices
FDA has cleared an Acclarent 510(k) to expand the indication for the Acclarent Aera Eustachian Tube Balloon Dilation System to include its use in patients as young as 18. The device was previously cleared only for adults aged 22 and older. In addition, the company says recent evidence shows
Drugs
FDA has accepted for review a Tetraphase Pharmaceuticals NDA for eravacycline for treating complicated intra-abdominal infections. The user fee review action target date was set for 8/28. The submission includes data from the IGNITE1 and IGNITE 4 Phase 3 clinical trials and showed that twice-daily eravacycline was
Drugs
Synergy Pharmaceuticals is petitioning FDA to require changes to the approved package insert for Forest Laboratories’ Linzess (linaclotide) to ensure that it contains adequate information for its use because it “misrepresents or obfuscates the incidence of adverse events in its clinical trials in several respects.” The petition says a Forest
Drugs
FDA commissioner Scott Gottlieb says the agency is taking new steps to support and expedite development of rare disease products. Writing in an FDA Voice blog post to mark 2/28 as the 11th Rare Disease Day, Gottlieb identifies the actions as: * a new pilot for more efficient orphan designation
Drugs
FDA has approved Eli Lilly’s Verzenio (abemaciclib) in combination with an aromatase inhibitor (AI) as initial endocrine-based therapy for treating postmenopausal women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced or metastatic breast cancer. This is the third indication for Verzenio within five months;
FDA Policy/General
Federal Register notice: FDA has announced a 3/27 Psychopharmacologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a U.S. WorldMeds NDA for lofexidine hydrochloride, indicated for mitigating symptoms associated with opioid withdrawal and facilitating completion of opioid discontinuation treatment. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 3/20 public meeting entitled “Promoting the Use of Complex Innovative Designs in Clinical Trials.” The meeting is intended to seek input on the agency’s development of a guidance document that is required by the 21st Century Cures Act and the FDA
Drugs
FDA says Hospira is recalling three lots of labetalol hydrochloride injection 100 mg/20 mL vial and one lot of labetalol hydrochloride injection to the hospital/institution level due to discovery of cracks on the rim surface of vials for the lots, which is covered by the stopper and crimp
FDA Policy/General
Federal Register notice: CDER has announced a 4/3 public workshop entitled “CDER and You: Keys to Effective Engagement.” The workshop is intended to build on previous efforts to help stakeholders understand how they can engage with the Center to enhance drug development and safety. To view the notice, click
Devices
Medtronic has begun a Class 1 recall of its Cardiac Resynchronization Therapy with Defibrillation and Implantable Cardiovert-Defibrillators due to a defect in the manufacturing process. The devices are intended to provide pacing for slow heart rhythms, and electrical shock or pacing to stop dangerously fast heart rhythms. Affected devices
FDA Policy/General
Federal Register notice: FDA has made available a guidance on “Q11 Development and Manufacture of Drug Substances — Questions and Answers (Chemical Entities and Biotechnological/Biological Entities).” The document, which was prepared under the direction of the International Council for Harmonization (ICH), includes questions and answers that were developed to clarify
Devices
FDA, the Centers for Disease Control and Prevention, and the American Society for Microbiology have announced the availability of voluntary, standardized duodenoscope surveillance sampling and culturing protocols to help reduce the risk of infection and increase the safety of the medical devices. The protocols are an update to an interim
Drugs
FDA is expected to release soon two new draft guidances intended to advance medication-assisted treatment (MAT) for opioid addiction. Speaking at the 2/24 National Governors Association annual meeting in Washington, DC, HHS secretary Alex Azar said one guidance will encourage more flexible and creative MAT study designs. “As
Biologics
FDA commissioner Scott Gottlieb says the agency is investigating why this year’s flu vaccine was not very effective against one strain — H3N2. “We’re taking steps to investigate each of [the] potential causes, rule out possible reasons for the variation in effectiveness and improve vaccine efficacy against H3N2,” he
FDA Policy/General
24 ANDA Approvals Withdrawn Federal Register notice: FDA withdraws approval of 24 ANDAs from multiple applicants because the products are no longer marketed. 02/23/2018 Regulatory Review Period Determined for Zydelig Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for ICOS Corp.