FDA Policy/General
Federal Register Notice: FDA will hold a two-day public hearing 9/12-13 to obtain input on four draft guidance documents relating to the regulation of human cells, tissues, and cellular and tissue-based products (HCT/Ps). The draft guidances are: Same Surgical Procedure Exception under 21 CFR 1271.
Devices
Rep. Jim Langevin (D-RI), who co-chairs the Congressional Cybersecurity Caucus, is supporting FDA’s draft guidance on “Postmarket Management of Cybersecurity in Medical Devices.” In a 4/21 letter to the agency, Langevin said the guidance, when finalized, should help improve medical device cybersecurity. “The risk-based nature
Drugs
FDA has removed from its import alert NeuroDerm’s third-party manufacturer of infusion pumps used to deliver the investigational drug ND0612 in its current clinical trials. The alert was ordered on Can SpA’s devices 7/2015 after FDA sent it a Warning Letter requesting additional documentation pertaining to
Devices
In a rare move, FDA has proposed a ban on electrical stimulation devices (ESDs) used for self-injurious or aggressive behavior because they present an unreasonable and substantial risk to public health that can’t be addressed in product labeling. ESDs send electrical shocks through electrodes attached to the skin
Devices
FDA has cleared a Fiagon 510(k) for its brain navigation software, BiopsyPointer FlexPointer 1.5 and the ShuntPointer. The device uses an electromagnetic tracking system to locate surgical instruments during a surgery in relation to a patient’s CT scan. It relies on instruments that have a proprietary “chip
Drugs
Six patients claiming they were harmed by Johnson & Johnson’s Levaquin have amended their federal lawsuit in Washington, DC District Court against the company, former FDA commissioner Margaret Hamburg and her husband Peter Brown, alleging violations of the Racketeering and Corrupt Organizations Act, the Lanham Act, and a variety
Drugs
FDA has accepted for review a Lundbeck NDA resubmission for an intravenous formulation of the anti-epileptic drug carbamazepine. The resubmission was in response to a 2014 complete response letter from the agency that requested additional data associated with product’s chemistry, manufacturing and controls. The proposed U.S. trade
FDA Policy/General
Federal Register Notice: FDA is extending the comment period for the draft guidance documents entitled Same Surgical Procedure Exception: Questions and Answers Regarding the Scope of the Exception; Minimal Manipulation of Human Cells, Tissues, and Cellular and Tissue-Based Products; Human Cells, Tissues, and Cellular and Tissue-Based Products from
Drugs
FDA says that clinical and bioanalytical studies conducted for drug companies by Semler Research Private Limited, located in Bangalore, India, are not acceptable as a result of data integrity concerns and must be repeated. A notice to drug companies says that Semler is a contract research organization that conducts bioequivalence
Drugs
Vifor Fresenius is asking FDA to grant five-year new active ingredient exclusivity to its Velphoro (sucroferric oxyhydroxide). A 4/15 petition also asks the agency to stay the acceptance, receipt, filing, review, and approval of any ANDA or 505(b)(2) application referencing Velphoro while it continues to consider
Devices
A Texas federal court jury has ruled that Abbott did not “cause” providers to submit false Medicare payment claims for off-label use of biliary stents as a whistleblower had alleged. Attorney James Holloway (Ober Kaler) writes in an online blog post that it is important for providers to recognize
Drugs
While it may seem that fewer Phase 2 and 3 studies would be needed for a fixed-dose drug-drug combination product using two drugs that have already been approved, in fact they often require more studies than single component products, according to a Camargo Pharmaceutical Services 505(b)(2)
Devices
FDA’s Orthopedic and Rehabilitation Devices Panel has voted 10 to 2 to recommend approval for a Cartiva PMA for its synthetic cartilage implant for treating degenerative and post-traumatic arthritis in the first metatarsophalangeal joint. The panel based its decision on data from the company’s MOTION study, which
Devices
FDA has cleared a Hologic 510(k) for the Affirm prone biopsy system that offers both 2D and 3D imaging-guided breast biopsies. The device provides a larger field of view than current systems, which allows radiologists to better target lesions found during 3D mammography exams, as well as other
FDA Policy/General
The House Appropriations Committee has approved a 2017 funding bill that would provide FDA $2.7 billion in discretionary spending, a $33 million (1%) increase over fiscal year 2016 spending levels. Including revenue from user fees, total 2017 funding is $4.78 billion – $97.4 million (2%) more than 2016.
Drugs
FDA medical reviewers say that clinical data submitted by Sarepta Therapeutics to support its NDA for eteplirsen to treat Duchenne muscular dystrophy (DMD) “overall did not provide statistical evidence to support the efficacy” of the drug. The assessment is part of a briefing document released in advance of a 4/
Devices
Nephros, Inc. has submitted a special 510(k) application to FDA for its Endopur ultrafilter designed to provide hemodialysis quality water. The company says the cartridge, offered in 10", 20", 30" and 40" sizes, is intended to be used as an endotoxin filter in a dialysis
Drugs
FDA’s Office of Orphan Products Development has granted orphan drug designation to DelMar Pharmaceuticals for its first-in-class small-molecule chemotherapeutic VAL-083 to treat ovarian cancer. According to the company, in over 40 Phase 1 and 2 clinical studies sponsored by the U.S. National Cancer Institute,
Drugs
ProbioTech is asking FDA to change the definition of a dietary supplement under the Dietary Supplement Health and Education Act and to treat probiotic suppositories the same as oral probiotic dietary supplements. A 4/7 petition says that probiotics that are not in the form of a pill, capsule, tablet,
Drugs
An FDA Office of Criminal Investigations probe has led to a Norfolk, VA man pleading guilty to one count of misbranding a drug and selling a drug outside of a legitimate supply chain. Patrick Simanjuntak, who sold insulin on Craigslist to an undercover FDA agent, will be sentenced on 8/
Drugs
FDA Office of International Programs China Office director Leigh Verbois says that China Office staff members spent five days touring the Yangtze River Delta region to meet with counterparts and share information. Writing in an FDA Voice blog post, Verbois says that the region is home to a significant number
Devices
FDA has cleared an Oculus Innovative Sciences 510(k) for the Microcyn-based Lasercyn Gel, intended for use for managing post-non-ablative laser therapy procedures, post-microdermabrasion therapy and following superficial chemical peels. Lasercyn may also be used to relieve itch and pain from minor skin irritations, lacerations, abrasions