Drugs
Six bipartisan House Energy and Commerce Committee leaders 1/17 wrote FDA commissioner Stephen Hahn seeking information on the agency’s processing of complex generic drugs. Their four-page letter said they were interested in lowering the costs of prescription drugs generally, but the number of complex generic drugs being
Drugs
TG Therapeutics has begun a rolling NDA submission for umbralisib, an oral, once-daily, dual inhibitor of PI3K-delta and CK1-epsilon for treating patients with previously treated marginal zone lymphoma (MZL) and follicular lymphoma (FL). The company says it has requested accelerated approval after receiving guidance from the agency
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h” (OMB Control Number 0910-0338). To view the notice, click here.
Devices
A new CDRH Learn module tells new manufacturers and importers about the FDA requirements for radiation-emitting products. In the Web video presentation, CDRH electrical engineer Lowell Howard reviews agency regulations and describes its role in regulating radiation-emitting electrical products. He says that manufacturers of radiation-emitting electrical products
Devices
FDA has announced a 3/5 public workshop entitled “Medical Extended Reality: Toward Best Evaluation Practices for Virtual and Augmented Reality in Medicine.” The workshop will discuss evaluation techniques for hardware, standards development, and assessment challenges for applications involving “extended reality (XR)” in medicine. Experts says that XR technologies, which
Drugs
Mindbreeze, described as a leading provider of appliances and cloud services for knowledge management, says it is working with the consulting firm Booz Allen Hamilton to deliver search capabilities for the CDER regulatory review community. “The intelligent Mindbreeze InSpire solution was successfully launched in October to provide broad search capabilities
Drugs
FDA has granted Arena Pharmaceuticals a fast track designation for APD418, a β3-adrenergic receptor antagonist and cardiac myotrope for treating decompensated heart failure. The company describes the selective antagonist as being designed to improve cardiac contractility with minimal effect on heart rate, blood pressure and myocardial oxygen consumption, thus
Drugs
FDA has denied an Otsuka 8/23/19 petition asking the agency to declare that its Samsca (tolvaptan) 60 milligram tablets were withdrawn for safety reasons. The petition also asked that FDA not approve any pending ANDA for generic Samsca and suspend and withdraw approval of any ANDA for a
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) issued 10 enforcement letters in 2019 addressing communications carried in 11 different communications vehicles. Eye on FDA reports that violations were nearly evenly divided between digital communication vehicles (five violations) and traditional vehicles (six violations). Other findings in the analysis: * no single
Drugs
ResMed Corp. (San Diego, CA) has agreed to pay more than $37.5 million to resolve alleged False Claims Act violations for paying kickbacks to medical equipment suppliers, sleep labs and other health care providers, according to the Justice Department. “Paying any type of illegal remuneration to induce patient referrals
Devices
CDRH director Jeffrey Shuren says FDA agrees with a Cardinal Health recommendation that customers immediately discontinue using affected Level 3 surgical gowns and PreSource procedural packs containing the gowns because the manufacturer cannot provide assurance that the products are sterile. An FDA notice says the company alerted customers to potential
Drugs
FDA has posted online information about the Right to Try Act that was signed into law 5/30/18. “This law is another way for patients who have been diagnosed with life-threatening diseases or conditions who have tried all approved treatment options and who are unable to participate in
Drugs
FDA has approved an ANI Pharmaceuticals ANDA for potassium citrate extended-release tablets USP, 10 mEq and 15 mEq, indicated for managing renal tubular acidosis with calcium stones, hypocitraturic calcium oxalate nephrolithiasis of any etiology, and uric acid lithiasis with or without calcium stones. U.S. annual sales for the
Devices
FDA has cleared a Cleveland Clinic 510(k) for patient-specific airway stents developed by Cleveland Clinic physician Tom Gildea. The devices are used to keep airways open in patients with serious breathing disorders, such as those caused by tumors, inflammation, or trauma. Previously, the patient-specific devices were being
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Pediatric Study Plans for Oncology Drugs: Questions and Answers.” The document provides information about the submission of an initial pediatric study plan for oncology drugs only. FDA has received a number of questions and the draft addresses the most
Devices
Attorneys Jeffrey Gibbs and McKenzie Cato (Hyman, Phelps & McNamara) document the slow disappearance of advisory panel meetings for PMA applications. Writing in their firm’s FDA Law Blog, the two say there were nine panel meetings in 2010, two in 2019, and none last year. They say the panel
Drugs
FDA has accepted for priority review a Clovis Oncology supplemental NDA for Rubraca (rucaparib) and its use as monotherapy treatment in adult patients with BRCA1/2-mutant recurrent, metastatic castrate-resistant prostate cancer. The agency has set a 5/15 user fee review action target date. Clovis describes rucaparib as
Devices
FDA has accepted for review a Neovasc PMA for its Neovasc Reducer for treating refractory angina. The device is intended to relieve angina symptoms by altering blood flow within the heart’s myocardium and increasing the perfusion of oxygenated blood to ischemic areas of the heart muscle, the company says.
Drugs
FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee has voted 27 to 0 to not recommend approval of Nektar Therapeutics’ oxycodegol for chronic low back pain. Based on the panel vote, the company said it would withdraw the NDA and stop
Drugs
FDA has updated the list of approved NDAs for biological products that will be deemed to be BLAs on 3/23. An agency updated notice says the list of products that will be deemed to be BLAs was prepared to enhance transparency and facilitate planning for the 3/23 transition.
Drugs
Attorneys from McDermitt Will & Emery say that in 2019 the CDER Office of Prescription Drug Promotion (OPDP) issued a total of six untitled letters and three Warning Letters, a slight increase over the 2018 total. Writing in their firm’s review of the year 2019 for FDA, they say
Drugs
FDA has approved a Lannett Co. NDA for cocaine hydrochloride nasal solution 4% (40 mg/mL), the company’s first branded local anesthetic product indicated for the introduction of local anesthesia in the mucous membranes for diagnostic procedures and surgeries on or through the nasal cavities of adults. The 505(