Devices
The Justice Department says that three individuals have been arrested and charged in connection with a scheme to market the “QLaser” as a treatment for over 200 diseases and disorders, and for violating an earlier court order that was issued after the scheme was first uncovered. A department statement says
FDA Policy/General
FDA’s Center for Veterinary Medicine (CVM) said 2/1 it had approved four NADAs for virginiamycin products submitted by Phibro Animal Health Corp. and Huvepharma EOOD for administration in feed to broiler and fryer chickens. They were among 11 actions, including two suitability petitions, taken by CVM during January.
Drugs
Eleven House members led by Reps. Kurt Schrader (D-OR) and Gus Bilirakis (R-FL) have introduced legislation they say will lower the cost of prescription drugs by providing review voucher incentives to drug makers to develop generic drugs when competition does not already exist or when there is a
Drugs
A WilmerHale review of the False Claims Act (FCA) in 2016 predicts that FCA enforcement is likely to remain vigorous, particularly in cases involving contractors. The review notes that at his confirmation hearing, attorney general-designate Jeff Sessions said that “this government must improve its ability to protect the United
Devices
FDA has posted a revised Medical Device Single Audit Program P0008 audit time determination procedure and related forms. The document contains six revisions dated 1/24.
Devices
FDA has approved an expanded efficacy claim for Zimmer Biomet Holdings’ single-injection viscosupplement Gel-One Cross-linked Hyaluronate for treating knee pain associated with osteoarthritis. The 26-week efficacy claim is associated with the product’s treatment of pain in osteoarthritis of the knee in patients who have failed
Devices
FDA has cleared a Medtronic 510(k) for the CardioInsight Noninvasive 3D Mapping System, intended for use in mapping irregular heart rhythms in the upper and lower chambers of the heart, and providing electroanatomic 3D maps of the heart. Cardiac mapping has traditionally been processed by inserting a catheter into
Drugs
FDA has approved an Allergan supplemental NDA for Avycaz (ceftazidime and avibactam) to include clinical data from two Phase 3 trials in the labeling that supports the indication to treat patients with complicated urinary tract infections (cUTI), including pyelonephritis, caused by designated susceptible Gram-negative microorganisms. In Trial 1, known
Drugs
FDA regulatory consulting firm Greenleaf Health has hired recently retired CDER Office on New Drugs (OND) director John Jenkins as principal for drugs and biologics. Jenkins retired last month after almost 25 years at FDA, and nearly 32 years of federal government service. He joined the agency in 1992 as
Drugs
Skadden Arp attorneys have issued a paper analyzing several documents FDA issued in the waning hours of the Obama administration staking out a strong position on its ability to regulate manufacturer communication on off-label uses. “Because the identity of the next FDA commissioner is still unknown,” the paper says,
Drugs
FDA has released the FDA-483 from a 10/5-10/23/15 inspection at CP Pharmaceuticals, Wrexham, UK. The document lists these observations: * failing to establish and follow procedures to prevent microbiological contamination of drug products purporting to be sterile; * aseptic processing areas are deficient regarding the system for
Drugs
A 1/11-1/19/16 FDA inspection at Facta Farmaceutici, Milan, Italy, found significant violations of current good manufacturing practice regulations in its production of finished pharmaceuticals, according to a 1/13 Warning Letter. Significant violations included: * failing to ensure that laboratory records included complete data derived from all
Devices
A 3/7-3/10/16 FDA inspection at Biotronik SE & Co., Berlin, Germany, found Quality System Regulation violations in the firm’s manufacturing of Selectra percutaneous catheters, Galeo coronary guide wires, implantable pacemakers, and implantable cardioverter defibrillators. A just-released 9/1/16 Warning Letter says that specific
FDA Policy/General
An eye-tracking research study conducted by FDA finds that even if TV direct-to-consumer ads present risk information through both audio and superimposed text, distracting visuals can keep consumers from focusing on key information in the ad and should be avoided. The results were published in the Journal
Devices
FDA has cleared two devices made by NICO Corp. that are used in a new approach to brain surgery. NICO received 510(k) clearance for specific neurosurgical indications on its Myriad automated tissue removal handpiece. The new clearance provides specific disease state approval for primary and secondary brain tumors, vascular
FDA Policy/General
FDA has denied a 10/4/16 petition submitted by an individual identifying himself as Mario Morais asking that the agency amend an administrative procedure to require that it file a final response to every citizen petition within a certain number of days after issuing a tentative response. The denial
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Biotronik SE & Co. Berlin, Germany (9/1/16): FDA inspected the firm 3/2016 and cited GMP violations associated with the manufacture of Selectra percutaneous catheters, Galeo coronary
Drugs
FDA has accepted for review an OptiNose NDA for OPN-375 and its use in treating nasal polyposis in adults. The company expects a user fee review action in September. The submission includes data from more than 1,500 patients and includes two global Phase 3 dose-ranging pivotal efficacy
Drugs
House Energy and Commerce Committee ranking member Frank Pallone, Jr. (D-NJ), Health Subcommittee ranking member Gene Green (D-TX), and Oversight & Investigations Subcommittee ranking member Diana DeGette (D-CO) 1/30 sent a letter to president Trump asking for clarification on FDA’s hiring authority in the wake
Drugs
A lengthy online story for Vox questions whether a Silicon Valley approach that reduces or eliminates FDA’s efficacy requirements for new drugs could work. The article says it appears that the Trump administration is using PayPal founder Peter Thiel to help review candidates for the position of FDA commissioner.
Devices
The 21st Century Cures Act provides some clarity on categories of software that are excluded from the statutory medical device definition and thus FDA jurisdiction, according to attorney Suzan Onel (Kleinfeld Kaplan & Becker.) Writing in an online Alert, Onel says that even with the clarification, some questions remain, particularly
Devices
A 1/18-1/21/16 FDA inspection at Ropack, Inc., Montreal, Canada, found 12 Quality System Regulation violations in the firm’s manufacturing of artificial saliva. Specific violations noted on an FDA-483 included: * failing to ensure that when the results of a process cannot be fully verified by