Devices
CDRH director Jeffrey Shuren has told The MedTech Conference in Boston that FDA may be willing to make public which devices are awarded breakthrough designation. He also said he predicts that the number of breakthrough devices getting final marketing approval will spike in about a year. MedTechDive reports online that
Drugs
A systematic review and meta-analysis conducted by researchers from several locations around the world found that the magnitude of treatment effects was some 2.5-fold higher among treatments that were approved based on non-randomized clinical trials (RCTs) than among treatments that required further testing in RCTs. Writing
Drugs
FDA has renewed the legacy licenses for Certara’s Synchrogenix division’s electronic common technical document (eCTD) review software, GlobalSubmit Review and GlobalSubmit Validate, for another year. The agency has been using the software since 2005. Certara says the licenses provide enterprise-wide use of the GlobalSubmit software for more
FDA Policy/General
Federal Register notice: FDA has determined that Hospira’s atropine sulfate ansyr plastic syringe (atropine sulfate solution) intravenous, intramuscular, subcutaneous, and endotracheal, 0.5mg/5 mL, was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Med-El Electromedizinische Gerate’s medical device Med–El EAS, intended to provide electrical stimulation to the mid- to high-frequency region of the cochlea and acoustic amplification to the low-frequency regions, for candidates
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Human Tissue Intended for Transplantation — 21 CFR Part 1270” (OMB Control Number 0910-0302). FDA’s regulations provide for FDA inspections of persons and tissue establishments engaged in the recovery, screening, testing, processing, storage, or distribution of
Devices
FDA has published a draft guidance, Providing Regulatory Submissions for Medical Devices in Electronic Format—Submissions Under Section 745A(b) of the Federal Food, Drug, and Cosmetic Act, to meet an FDA Reauthorization Act requirement that it issue by 10/1 a draft guidance providing for further standards for the
FDA Policy/General
House Energy and Commerce chair Frank Pallone (D-NJ) says the current youth vaping epidemic could have been averted if FDA in 2017 had not delayed reviewing e-cigarettes that are on the market. In exercising its enforcement discretion, FDA has given e-cigarette makers until 5/2020 to submit
Drugs
FDA has granted breakthrough therapy designation for Achillion Pharmaceuticals’ danicopan for treatment in combination with a C5 monoclonal antibody for patients with paroxysmal nocturnal hemoglobinuria who are sub-optimal responders to a C5 inhibitor alone. The agency’s decision reportedly was based on positive safety and efficacy data from an
Devices
FDA has approved Abiomed’s newest heart pump, the Impella 5.5 with SmartAssist, indicated for temporary ventricular support (14 days) and for treating ongoing cardiogenic shock that occurs immediately (less than 48 hours) following acute myocardial infarction or open heart surgery or in the setting of cardiomyopathy. The company
Devices
FDA has granted Aurora Concussion Therapy Systems a breakthrough device designation for its Aurora Light Therapy System for treating concussions. The device applies a near-infrared light to energize the brain’s metabolic cascade process and accelerate the healing process for concussions and other mild brain trauma. The company says
Drugs
Florida has submitted a “Canadian Prescription Drug Importation Concept Paper” to HHS in hopes of satisfying federal requirements to import prescription drugs from Canada. The plan was authorized in legislation signed by the state’s governor 6/12/19. Implementation requires an HHS determination that the importation will pose no
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.” The document focuses on applications, perceived barriers, and common challenges of patient engagement in designing and conducting medical device clinical investigations. To view the notice, click here.
Biologics
The White House has issued a Fact Sheet saying that President Donald Trump has signed an executive order “to modernize influenza vaccines and help protect more Americans through vaccination.” The sheet says the administration will work to promote new technologies to improve vaccine manufacturing and effectiveness, reducing reliance on more
Drugs
FDA has posted an updated list of approved NDAs for biological products that will be deemed to be BLAs as of 3/23/20. An online notice says that to “enhance transparency and facilitate planning for the 3/23/20 transition date, FDA posted a preliminary list of approved applications
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Wholesale Distributor Verification Requirement for Saleable Returned Drug Product — Compliance Policy.” The document describes FDA’s intention regarding enforcement of the Drug Supply Chain Security Act provision requiring wholesale distributors to (XXX INSERT XXX)verify a product identifier prior
FDA Policy/General
Federal Register notice: FDA is seeking comments related to post-marketing pediatric-focused safety reviews of products posted between 4/12 and 9/23 on the agency’s Web site but not scheduled to be presented at the 9/26-27 Joint Pediatric Advisory Committee and Drug Safety and Risk
FDA Policy/General
Federal Register notice: FDA has announced a 10/29 Bone, Reproductive and Urologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss an Amag Pharmaceuticals supplemental NDA for Makena (hydroxyprogesterone caproate injection), 250mg/ml, for reducing the risk of preterm birth in women with a singleton pregnancy who have
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) outlining the process to be followed when the Division of Medication Error Prevention consults the Division of Medical Policy Programs for review of patient-oriented labeling for drug products that are intended for use by patients, caregivers, or both. The
Drugs
A 3/21-4/9 FDA inspection at the Nutra Solutions contract dietary supplement manufacturing facility in Deer Park, NY, found serious violations of current good manufacturing practice (CGMP) regulations for manufacturing, packaging, labeling, or holding operations for dietary supplements. A 9/12 Warning Letter says the significant violations were:
Drugs
The Federal Trade Commission (FTC) has written to seven unidentified legal practitioners and lead generators expressing concern that some TV ads soliciting clients for personal injury lawsuits against drug manufacturers may be deceptive or unfair under the commission’s law. A commission news release says the letters state that some
Drugs
Responding to an FDA-483 inspection report, AveXis says it has terminated two senior executives over self-reporting to FDA of data manipulation issues involving a mouse potency assay used as a product release test during the early clinical phase of its Zolgensma (onasemnogene abeparvoec-xioi). A company letter to