Drugs
FDA has approved Ipsen’s NDA for Sohonos (palovarotene) capsules as a retinoid indicated to reduce in volume new heterotopic ossification in adults and pediatric patients aged 8 and older for females and 10 and older for males with fibrodysplasia ossificans progressiva (FOP). The company says it is the first
Devices
FDA says the Datascope/Maquet/Getinge 6/5 recall of Cardiosave Hybrid and Rescue intra-aortic balloon pumps for printed circuit board assembly failures is Class 1. An agency notice says the company recalled 4,586 devices distributed in the U.S. between 5/6/2012 and 5/19/2023.
Devices
FDA has granted BlueWind Medical a de novo marketing authorization request for the Revi System, a tibial neuromodulation therapy for treating the symptoms of urgency incontinence alone or in combination with urinary urgency. The authorization was based on results from the OASIS pivotal trial, in which the device demonstrated a
FDA Policy/General
Federal Register notice: FDA is announcing a 9/18-19 public workshop entitled “Optimizing the Use of Postapproval Pregnancy Safety Studies.” It will include discussions about designs of postapproval pregnancy safety studies for drug/biologic products and experiences with implementing these studies. The workshop also will discuss a proposed framework
Drugs
Vanda Pharmaceuticals is pushing back on a proposed order drafted by CDER in which FDA commissioner Robert Califf would refuse to either grant summary judgment to the company and approve its sNDA for a new indication for Hetlioz (tasimelteon) to treat jet lag disorder or hold a hearing on the
Drugs
Attorney Douglas Farquhar (Hyman, Phelps & McNamara) says the current situation in which a larger than usual percentage of OAI (official action indicated) drug company inspections results in the exercise of FDA enforcement discretion may not continue. Writing in his firm’s FDA Law Blog, Farquhar reports on a presentation
Drugs
The FDA National Center for Toxicological Research says its PathologAI initiative is intended to develop an effective and accurate framework for the analysis of histopathological data from animal studies to advance digital pathology in preclinical application. An online post says PathologAI “may quickly and accurately identify and quantify specific lesion
FDA Policy/General
Federal Register notice: FDA is announcing a 10/4 Oncologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss a World Meds NDA for eflornithine tablets, indicated for reducing the risk of relapse in pediatric patients with high-risk neuroblastoma who have completed multiagent, multimodality therapy. To view the
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Informed Consent: Guidance for Institutional Review Boards, Clinical Investigators, and Sponsors.” The document is intended to help stakeholders carry out their responsibilities related to informed consent. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is reopening the comment period for a 6/8 draft guidance entitled “Demonstrating Bioequivalence for Type A Medicated Articles Containing Active Pharmaceutical Ingredient(s) Considered To Be Poorly Soluble in Aqueous Media, That Exhibit Little to No Systemic Bioavailability, and Are Locally Acting.” Electronic or written
Drugs
CDER researchers have identified several common deficiencies found in regulatory submissions involving the use of continuous manufacturing (CM) and/or real-time release testing for dissolution (RTRT-D). Writing in the Journal of Pharmaceutical Sciences, the researchers say their intent is to provide recommendations for best practices that will help
Drugs
A 1/5-2/9 FDA inspection at the Denison Pharmaceuticals drug manufacturing facility in Lincoln, RI, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs, and other violations. A 7/26 Warning Letter says specific CGMP violations were: * failing to thoroughly investigate any unexplained discrepancy
Devices
CDRH says it prefers public comments on its guidance documents that are submitted in a “table format” because it facilitates the Center’s analysis and compilation of comments received. This preference is suggested in a new CDRH Web page on “Tips for Submitting Comments on CDRH Guidance Documents.” The table
Devices
FDA has cleared a CathVision 510(k) for the PVI Analyzer and Signal Complexity algorithms as part of the Cardialytics suite of artificial intelligence (AI)-powered analytics integrated into the ECGenius System, an electrophysiology (EP) recording system. The AI algorithms are intended to assist in electrogram interpretation to help physicians
Drugs
FDA has accepted a Servier sNDA and will give priority review for Tibsovo (ivosidenib) to treat IDH1-mutated relapsed or refractory myelodysplastic syndromes (MDS). A company statement says that if the indication is approved, Tibsovo would be a first-in-class targeted therapy option for MDS patients within the molecularly
Drugs
The Fifth Circuit Court of Appeals has ruled that the abortion drug mifepristone can remain on the market while litigation continues, but it should be available under the conditions for use that existed in 2016 until final judgment. In 2016, FDA approved a supplemental NDA that removed several restrictions on
Drugs
Federal Register notice: FDA is issuing an order debarring Ildiko M. Knoll for five years from importing or offering for import any drug into the U.S. The order is based on an FDA investigation that showed Knoll imported 100 parcels (18,435 pieces; 9,495 tablets) containing erectile dysfunction
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) issued an 8/4 Warning Letter to AstraZeneca about a professional sales aid for its Breztri Aerosphere (budesonide, glycopyrrolate, and formoterol fumarate) inhalation aerosol for oral inhalation use. The letter is the first Warning Letter issued by OPDP this year. “The sales
Drugs
FDA has published a guidance, Informed Consent Guidance for IRBs, Clinical Investigators, and Sponsors, to assist institutional review boards (IRBs), clinical investigators, and sponsors in complying with the agency’s informed consent regulations for clinical investigations. The document supersedes a 9/1998 guidance and finalizes a 7/2014 draft guidance.
Devices
A 3/1-5/17 FDA inspection at TEI Biosciences in Boston, MA, an Integra LifeSciences company, found Quality System (QS) regulation violations in the firm’s manufacturing of collagen-based medical devices, such as Durepair, used for wound care, soft tissue repair, and reconstruction surgery. A just-released 7/
Drugs
FDA has lifted a partial clinical hold against an Arcellx IND for CART-ddBCMA, an investigational drug for treating patients with relapsed or refractory multiple myeloma. The hold was ordered in June following a recent patient death. At the time, the company said it believed “limitations on bridging therapy are
Drugs
FDA has approved Delcath Systems’ Hepzato Kit (melphalan for injection/hepatic delivery system) for liver-directed treatment in adult patients with uveal melanoma with unresectable hepatic metastases affecting less than 50% of the liver and no extrahepatic disease, or extrahepatic disease limited to the bone, lymph nodes, subcutaneous tissues, or