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Federal Register notice: FDA has made available a draft guidance entitled “Pediatric Study Plans for Oncology Drugs: Questions and Answers.”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(
Drugs
The FDA Anesthetic and Analgesic Drug Products Advisory Committee will discuss 1/16 Durect Corp.’s 10/2019 response to a 2/12/14 FDA complete response letter for its Posimir (bupivacaine extended-release solution) with a proposed indication for administration into a surgical incision to produce post-surgical analgesia.
FDA Policy/General
Eight FDA staffers say they envision that machine learning will play an increasingly important role in future drug development and regulation. Writing in Clinical Pharmacology and Therapeutics, they say (membership or purchase required) that machine learning “will likely be an essential tool for data aggregation, information synthesis, pattern recognition, and
Devices
CDRH associate director for compliance and quality Erin Keith says the number of Warning Letters issued by the Center may start to climb this year as reorganization bugs that prevented sending letters on time are worked out. However, not all observers agree that reorganization is the only cause for a
Drugs
Republican leaders of the House Energy and Commerce Committee say they are reopening their 8/2018 inquiry into three opioid manufacturers — Insys, Mallinckrodt, and Purdue — to obtain additional information from the companies. In 2018, the companies were asked to provide information about their actions related to the spread of the
Drugs
A new FDA safety alert says that results from a clinical trial assessing safety of Eisai’s weight-loss drugs Belviq and Belviq XR (lorcaserin) show a possible increased cancer risk. The alert says that the cancer cause is “uncertain” and that the agency cannot conclude that lorcaserin contributes to
Drugs
FDA has placed a partial clinical hold on Innate Pharma’s TELLOMAK Phase 2 trial that is evaluating lacutamab’s efficacy and safety in patients with advanced T-cell lymphomas. The company says it has been in ongoing discussions with regulatory authorities about GMP deficiencies at its manufacturing subcontractor site
Drugs
Harvard Medical School researchers say that while the FDA approval and regulation processes for drugs have evolved and increased in complexity over the last four decades as special programs have been added and the use of surrogate measures has been encouraged, the changes have not led to a reduction in
Devices
FDA has cleared a BioCardia 510(k) for the Morph DNA deflectable guide catheter used to guide the Helix Biotherapeutic Delivery System during CardiAMP cell therapy delivery in the heart. The guide catheter is designed to improve procedural control of therapeutic catheters, such as the Helix system, during delivery of