Devices
FDA commissioner Scott Gottlieb told the American Clinical Laboratory Association annual meeting 3/6 that the agency is “working hard to make sure that as inventive new tests come to us for review, we have the right tools to evaluate cutting-edge technologies. And we have the right processes in
Devices
FDA has granted Polyganics a breakthrough device designation for its Liver and Pancreas Sealant Patch, which is designed to prevent fluid leakage after hepato-pancreato-biliary procedures. Currently, there are no approved or cleared alternatives to prevent such leakages, according to the company. The device is made from Polyganics’ proprietary
FDA Policy/General
Federal Register notice correction: FDA is correcting a 2/22 notice entitled “Peripheral and Central Nervous System Drugs Advisory Committee; Notice of Meeting.” The document was published with the incorrect docket number. The docket number is corrected to read “FDA-2018-N-0410.” To view the notice, click here.
Devices
FDA has announced a 4/18 public workshop on “Study Design Considerations for Devices including Digital Health Technologies for Sleep Disordered Breathing in Adults.” At the workshop, FDA will discuss appropriate clinical study designs for evaluating medical devices for diagnosing, monitoring, or treating the condition. Study design considerations include definitions
Drugs
A petition submitted by the Haynes and Boone law firm asks FDA not to approve any ANDA for a mycophenolate mofetil oral suspension product that relies on only metabolite data to establish bioequivalence to the reference-listed drug (Roche’s CellCept). The firm’s 3/6 petition also asks the
Biologics
FDA commissioner Scott Gottlieb says FDA needs to develop a science-based framework that includes the regulatory tools and guidances to evaluate cell-based and recombinant technology flu vaccines. “Ultimately, our investment will provide regulatory clarity for this kind of new technology,” Gottlieb said in 3/8 testimony before a
FDA Policy/General
Sen. Tom Cotton (R-AR) and three Republican and Democrat colleagues have introduced the Preserve Access to Cost Effective Drugs (PACED) Act to restore the power of the Patent and Trade Office and federal courts and the International Trade Commission to review patents regardless of sovereign immunity claims made as
Biologics
Verax Biomedical says FDA improperly influenced members of the Blood Products Advisory Committee at an 11/30/17 meeting in violation of the Federal Advisory Committee Act (FACA), and agency actions taken to implement recommendations from that meeting should be reversed. In a 3/5 petition, Verax asks that FDA:
Devices
A CDRH Webinar gave hints to improve compliance with the custom device annual report requirements. A custom device exemption allows medical device manufacturers to market certain devices designed to treat a unique pathology or physiological condition without premarket approval. Manufacturers of custom devices are to report to FDA annually. During
Drugs
FDA has accepted for review a TherapeuticsMD NDA for TX-001HR, an investigational bio-identical hormone therapy combination of estradiol and progesterone in a single, oral softgel for treating moderate-to-severe vasomotor symptoms due to menopause. The agency has set a user fee review action target of 10/28.
Drugs
FDA has given IDE approval to InVivo Therapeutics Holdings for a second pivotal clinical study involving the company’s Neuro-Spinal Scaffold in patients with acute spinal cord injury. The 20-patient, randomized, controlled trial is designed to complement existing clinical evidence from the company’s single-arm INSPIRE study.
FDA Policy/General
Federal Register notice: FDA has classified the extracorporeal shock wave device for treating chronic wounds into Class 2 (special controls). The action is in response to a 7/2016 Sanuwave, Inc. de novo classification request for its dermaPace System. The agency has codified the device classification by adding 21 CFR
Drugs
FDA commissioner Scott Gottlieb says he wants more agency investigators at international mail facilities to help intercept illegal drug shipments, particularly opioids disguised as other drugs and dietary supplements. Speaking to an Associated Press reporter 3/6, Gottlieb said he wants to more than double the number of packages his
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection for “Reclassification Petitions for Medical Devices — 21 CFR Section 860.123” (OMB Control Number 0910-0138). Reclassification provisions of the Food, Drug & Cosmetic Act allow any person to petition for reclassification of a device from any of the
Drugs
Addressing healthcare payors at the America’s Health Insurance Plans National Health Policy Conference, FDA commissioner Scott Gottlieb said payors are going to have to decide whether they want to continue to receive the short-term profit that comes with drug rebate programs or are willing to support a system
Drugs
A Tufts Center for the Study of Drug Development survey says that the clinical trial study initiation process remains highly inefficient with wide variation among companies, despite implementation of new technology solutions and practices. “The findings indicate that the site initiation process has become increasingly challenging for sponsors and contract
Drugs
Esperion has reported positive top-line results from a pivotal Phase 3 study (Study 4 or 1002-048) involving its investigational bempedoic acid 180 mg. The trial was designed to evaluate the LDL-C lowering efficacy and safety and tolerability of bempedoic acid versus placebo in patients with, or at
Devices
FDA has cleared a Stryker’s Spine division 510(k) for its Tritanium TL Curved Posterior Lumbar Cage, a 3D-printed interbody fusion device intended for use as an aid in lumbar fixation. The hollow implant has a “unique configuration of both solid and porous structures, which are simultaneously built
FDA Policy/General
Yale University researchers say their review of 97 unique direct-to-consumer (DTC) drug ads for 60 unique drugs found that few of the ads complied with FDA regulations. “The overall quality of information presented in ads was low, and suggestions of off-label promotions were common for diabetes medications,
Drugs
FDA has cleared a Panther Orthopedics 510(k) for the Puma System, an implantable flexible fixation device indicated for syndesmosis fixation, hallux valgus reconstruction, and tarsometatarsal fixation. The device was designed to solve problems experienced with stiff metal screws, which serve as stress risers and prohibit normal physiological joint motion,
Devices
FDA says it received 11, 854 medical device reports related to Bayer’s Essure contraception device in 2017, more than double the 5,019 reports received in 2016. “The nature and severity of the reports remain consistent with prior years,” an FDA Essure activity update says. “However, in 2017, 78%
Devices
The 3rd Circuit Court of Appeals has issued the first appellate decision that preemption for multi-component medical devices should be addressed on a component-by-component basis. Attorney Michelle Yeary (Dechert) says the ruling came in an appeal from a Pennsylvania federal court decision in a case involving a