Drugs
The number and size of federal and state settlements against the pharmaceutical industry remained low in 2016 and 2017, with federal criminal penalties nearly disappearing, according to an analysis published by Public Citizen. The report updates data that the advocacy group previously released in 2016 on criminal and civil settlements
Devices
FDA says that Opternative, Inc., Chicago. IL, is marketing its On-Line Opternative Eye Examination Mobile Medical App device in the U.S. without FDA marketing clearance or approval. A just-released 10/30/17 Warning Letter says the product is considered a medical device because it is intended for
FDA Policy/General
Federal Register correction notice: FDA is correcting a final order entitled “Medical Devices; Hematology and Pathology Devices; Classification of Lynch Syndrome Test Systems” that appeared in the 2/27 Federal Register. The document was published with the incorrect docket number, and is now corrected to read “FDA–2018–N–0399.
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of four Sun Pharmaceutical ANDAs because the drug products are no longer marketed. Affected generic products include enalapril maleate tablets, lorazepam tablets, zolpidem tartrate tablets, and zoledronic acid for injection. To view the notice, click here.
Drugs
Attorneys Anne Walsh and Rachel Hunt (Hyman, Phelps & McNamara) say the Supreme Court is considering a Gilead petition asking it to rule on a question involving “materiality” in False Claims Act (FCA) cases. Writing in their firm’s FDA Law Blog, the attorneys say Gilead’s question arises from
FDA Policy/General
Federal Register notice: FDA has announced a 4/17 public meeting entitled “Patient-Focused Drug Development on Opioid Use Disorder.” The meeting will obtain patients’ perspectives on the impacts of and treatment approaches for opioid use disorder. It is part of FDA’s ongoing work aimed at reducing the impact
Drugs
FDA says Biogen and AbbVie are withdrawing their multiple sclerosis drug Zinbryta (daclizumab) from the global market due to concerns about the drug’s benefit/risk profile. In an online information sheet, the agency says it is working with the companies to help ensure a well-organized withdrawal from the
Biologics
FDA has accepted for review a Merz North America supplemental BLA for Xeomin (incobotulinumtoxinA) for treating chronic sialorrhea (excessive drooling) due to Parkinson’s Disease or other neurologic disorders in adult patients. The submission is based on a Phase 3 study, which Merz says met both of its co-primary
Devices
The 3rd Circuit Court of Appeals has followed views submitted by FDA in an amicus brief in a case involving allegations that the manufacturer of an artificial hip promoted the device illegally. A Washington Legal Foundation (WLF) online Legal Pulse says that on the question of whether the suit was
Devices
FDA has cleared an Exactech 510(k) for the Equinoxe Stemless Shoulder, a bone conserving and canal sparing prosthesis that is compatible with the Equinoxe Shoulder System. The device is designed for anatomic total shoulder arthroplasty, and it features a single tray of instruments for operating room efficiency. It uses
Devices
The Securities and Exchange Commission has charged Silicon Valley-based Theranos, its founder and CEO Elizabeth Holmes, and former president Ramesh Balwani with raising more than $700 million from investors through an elaborate fraud in which they exaggerated or made false statements about the company’s blood test, business, and
Drugs
The House of Representatives has failed to pass HR 5247, the Right to Try Act of 2018, under suspension of the rules. The bill (see earlier story) was crafted to improve access to experimental treatments for patients with terminal diseases or conditions. The vote was 259 to 140 in favor
Drugs
A 9/14-9/15/17 FDA inspection at Quali-Controle & Quali-Controle C.E.BAC, Meru, France, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 3/5 Warning Letter. Specific violations cited were: * failing to establish and document the accuracy, sensitivity,
Drugs
The President’s Cancer Panel is calling on President Donald Trump to make the dramatic rise of cancer drug prices a national priority that requires a “concerted, immediate, bipartisan, and multilateral effort.” In a report to Trump, the three panel members say they propose balanced solutions aimed at growing a
Devices
FDA has cleared a CereMetrix 510(k) for its neuroimaging analytics and quantification platform CereMetrix Silver. The device allows healthcare providers to have access to objective neuroimaging that detects, quantifies and analyzes brain function down to the voxel level, according to the company. The image viewer is designed to analyze
Biologics
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab) for treating patients with advanced cervical cancer that is progressing on or after chemotherapy. This is the first submission for an anti-PD-1 therapy in cervical cancer, and the agency has set a user fee review
Devices
Hyman, Phelps & McNamara says an FDA draft guidance on the concept and principles behind the “least burdensome” provisions is extremely important because the concept is a fundamental principle implicated by many FDA decisions that the agency still has not adequately implemented. “Repeated experience has shown that FDA has not
Drugs
FDA has placed on clinical hold an Advaxis IND for a Phase 1/2 combination study of axalimogene filolisbac with AstraZeneca’s Imfinzi (durvalumab) for treating patients with advanced, recurrent or refractory human papillomavirus (HPV)-associated cervical cancer and HPV-associated head and neck cancer. The company says the hold
Devices
A 12/4-12/14/17 FDA inspection at Laser Dental Innovations, a San Jose, CA, manufacturer of dental handpiece and laser fiber optic surgical devices, found Quality System Regulation violations, according to a 2/27 Warning Letter. Specific violations cited were: * failing to establish procedures for implementing corrective and
Drugs
Rep. Frank Pallone (D-NJ) has introduced HR 5228, the Stop Counterfeit Drugs by Regulating and Enhancing Enforcement Now (SCREEN) Act, to increase funding to and expand FDA authority to prevent illegally manufactured opioids, including heroin and fentanyl, from arriving through the mail from overseas.In a statement (includes link
Devices
An 8/28-8/31/17 FDA inspection at Dexcowin Co., Ltd., Seoul, Korea, found 13 violations of Quality System Regulations, according to a 2/20 Warning Letter. Specific violations cited were: * failing to establish and maintain adequate procedures for implementing corrective and preventive action; * failing to establish and maintain
Drugs
FDA has released the FDA-483 issued following a 2/6-2/15 inspection at Biocon Sdn Bhd, a Johor, Malaysia, sterile drug manufacturer. The inspection observations were: * failing to establish or follow procedures designed to prevent microbiological contamination of drug products purporting to be sterile; * failing to thoroughly review