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Federal Register notice: FDA has made available a draft guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.”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
Devices
FDA has approved a Cardiovascular Systems PMA for its ViperWire Advance Coronary Guide Wire with Flex Tip. The device is a combination of a flexible nitinol core with a shapeable floppy tip to help physicians navigate in complex anatomy, the company says. In addition, it says, the flexible nitinol body
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Amyotrophic Lateral Sclerosis (ALS): Developing Drugs for Treatment.” The document addresses the clinical development of drugs intended to treat the main motor aspects of ALS, i.e., muscle weakness and its direct consequences, including shortened life expectancy. It does
Drugs
FDA has placed a clinical hold on an Abeona Therapeutics planned Phase 3 clinical trial for EB-101 until it submits “additional data points on transport stability of EB-101 to clinical sites,” according to the company. “Over the last 12 months, the company has worked closely with the FDA
Drugs
University of Pennsylvania Abramson Cancer Center researchers say that within six months of an FDA move to restrict the labels of two immunotherapies, usage of the drugs among oncologists dropped about 50%. The researchers say the findings offer reassurance that oncologists “can be nimble enough to quickly incorporate the latest
Drugs
FDA has posted its latest batch of Warning Letters that includes one medical product company. It can be accessed by clicking on the link following the summary below: Nutra Solutions USA, Deer Park, NY (9/12): FDA inspected the dietary supplement manufacturing facility in March and cited significant GMP violations.
Biologics
FDA has approved Bavarian Nordic A/S’s Jynneos smallpox and monkeypox vaccine, live, non-replicating, who are determined to be at high risk for smallpox or monkeypox infection. It is the only FDA-approved vaccine for preventing monkeypox disease. The agency says that Jynneos will be available for those
FDA Policy/General
Federal Register notice: FDA has made available a draft guide entitled “The Accreditation Scheme for Conformity Assessment (ASCA) Pilot Program.” The program is authorized under the FDA Reauthorization Act of 2017 and the Medical Device User Fee Amendments of 2017. FDA believes the pilot may further encourage international harmonization of
Devices
FDA has released a draft guidance entitled “Patient Engagement in the Design and Conduct of Medical Device Clinical Investigations.” The document is intended to help sponsors with how they can use patient engagement to understand experiences, perspectives, and other relevant information from patient advisors. It is also intended to improve
FDA Policy/General
FDA has posted a draft Guidance for Industry (GFI) #263, “Recommendations for Sponsors of Medically Important Antimicrobial Drugs Approved for Use in Animals to Voluntarily Bring Under Veterinary Oversight All Products That Continue to be Available Over-the-Counter,” to help explain the recommended process for voluntarily changing the approved