Devices
FDA has cleared a BioElectronics 510(k) for its over-the counter (OTC) ActiPatch medical device and its expanded indication — adjunctive treatment of musculoskeletal pain. The device was originally cleared in 2017 for OTC treatment of pain from knee osteoarthritis and plantar fasciitis. The device uses electromagnetic pulse therapy for
Drugs
FDA has granted EyeYon Medical a breakthrough device designation for its EndoArt Artificial Endothelial Layer Implant. The polymer film implant is intended to be attached to the posterior corneal surface to treat chronic corneal edema secondary to endothelial dysfunction. A nonfunctioning endothelium results in corneal homeostasis loss due to excess
Drugs
Romark Laboratories, which manufactures and distributes Alinia (nitazoxanide) tablets for oral use and for oral suspension, indicated for treating some cases of diarrhea, is asking FDA not to approve any ANDA for a generic form of its products unless the applicant satisfies bioequivalence provisions proposed by Romark. The company’s
Drugs
FDA has announced a 3/5 workshop on “Advancing Animal Models for Antibacterial Drug Development.” The workshop is set to discuss ongoing research efforts to advance animal model development for serious bacterial infections. The agency will also discuss challenges encountered in animal model development and ideas for future research. Discussions
FDA Policy/General
Federal Register notice: FDA in collaboration with the Federal Trade Commission have announced a 3/9 public workshop: “FDA/FTC Workshop on a Competitive Marketplace for Biosimilars.” The workshop will discuss the agencies’ efforts to support appropriate adoption of biosimilars, discourage false or misleading communications about biosimilars, and deter anticompetitive
Drugs
FDA says that its 2/4-2/8/19 inspection of Evig LLC, doing business as Balance of Nature, St. George, UT, found serious violations of the Federal Food, Drug, and Cosmetic Act in the firm’s manufacturing and marketing of Whole Fruit Foods, Whole Food Veggies, and Whole Food
Devices
A 4/8-4/11/19 FDA inspection at Won Industry Co., Siheung-si, Republic of Korea, found Quality System Regulation violations in the firm’s manufacturing of the Morning Life Compression Limb Therapy System. The inspection was a follow-up to a 2015 inspection and found recurring violations. A
Drugs
FDA has issued a draft guidance, Mucopolysaccharidosis Type III (Sanfilippo Syndrome): Developing Drugs for Treatment, to make recommendations to sponsors about eligibility criteria, trial design considerations, and efficacy endpoints to enhance clinical trial data quality and foster greater efficiency in developmental programs for drugs to treat Sanfilippo syndrome. The document
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Promotional Labeling and Advertising Considerations for Prescription Biological Reference and Biosimilar Products — Questions and Answers.” The document provides information for sponsors to consider when developing FDA-regulated promotional labeling and advertisements for such products. To view the notice, click
Devices
GE Healthcare has begun a Class 1 recall of its CareScape Respiratory Modules and Airway Gas Option due to a manufacturing issue which may cause the devices to display incorrect oxygen values. Incorrect oxygen values could lead to high (hyperoxia) or low (hypoxia) blood oxygen levels in patients, according to
Drugs
In a 1/31 interview with Politico, new FDA commissioner Stephen Hahn stressed product safety as he talked about drug importation, generic drug approvals, cannabidiol products, and the coronavirus. Hahn was confirmed one day before the Trump administration announced its plan to allow states to import cheaper drugs from Canada.
Devices
FDA has approved a Conturais PMA for Bulkamid for treating stress urinary incontinence (SUI) due to intrinsic sphincter deficiency in adult women who have SUI or stress predominant mixed incontinence. The soft hydrogel comprises 2.5% polyacrylamide and 97.5% water, according to the company. Once injected, it says, (XXX
Drugs
FDA has approved an expanded label for Merck’s insomnia drug Belsomra (suvorexant) C-IV to include findings on its use for treating insomnia in patients with mild-to-moderate Alzheimer’s disease. Belsomra is indicated for the treatment of insomnia characterized by difficulties with sleep onset or sleep maintenance.
Devices
CDRH is using the 2019 ASCA Annual Report to detail progress made during the year toward an Accreditation Scheme for Conformity Assessment (ASCA) pilot program as required under the 2017 FDA Reauthorization Act. The report says the pilot “is anticipated to augment confidence in and reliance upon Declarations of Conformity
Drugs
ML Strategies senior director Aaron Josephson says changes are likely to be made in the medical product user fee programs that are starting the reauthorization process this year. In an online post, Josephson highlights some changes made to the programs when they were last reauthorized through the 2017 FDA Reauthorization
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Evig LLC (dba Balance of Nature), St. George, UT (8/20/2019): FDA inspected the company 2/2019 and cited serious violations of the Federal Food, Drug, and Cosmetic
Devices
FDA has issued a coronavirus emergency use authorization to permit the wider use of a Centers for Disease Control and Prevention (CDC) 2019-nCoV Real-Time RT-PCR Diagnostic Panel. To date, the reverse transcriptase polymerase chain reaction test has been limited to use at CDC laboratories. Testing is limited
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Planning for the Effects of High Absenteeism To Ensure Availability of Medically Necessary Drug Products.” The collection supports agency guidance that encourages drug/biologic manufacturers to develop a written emergency plan for maintaining an adequate supply of
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Application for Participation in FDA Fellowship and Traineeship Programs.” The collection involves brief online applications completed by applicants applying to FDA’s fellowship and traineeship programs. The process is intended to reduce the time and cost of
FDA Policy/General
Federal Register notice: FDA has renewed for two years its Vaccines and Related Biological Products Advisory Committee charter. The new charter will be in effect until 12/31/2021. To view the notice, click here.
Drugs
FDA has posted laboratory results showing N-Nitroso dimethylamine (NDMA) levels in some metformin products approved in the U.S. The testing, which is part of FDA’s ongoing investigation into NDMA impurities in certain drug products, showed that metforminֺ products range from “not detectable to low levels.” To date,
Drugs
A new Government Accountability Office (GAO) report on FDA’s priority review voucher (PRV) program shows that after a decade of experience, the vouchers have had little or no effecet on drug development. However, GAO says that the seven drug sponsors GAO interviewed said PRVs were a factor in drug