Drugs
Saranas has filed a de novo classification for the Early Bird Bleed Monitoring System, a device for use during endovascular procedures to detect the onset of bleeding. The system uses a “vascular access sheath with embedded sensors that are designed to detect and monitor bleeding from a blood vessel accidentally
Drugs
A Supreme Court decision in an energy company case held 7-2 that the inter partes review process for reviewing patents does not violate the Constitution. The case is likely to have a bearing on companies seeking to challenge biologic patents. The Center for Biosimilars says it was told by
Devices
Bayer has submitted to FDA a heavily redacted updated 12-month interim postmarket surveillance report on the company’s Essure 522 study. The company says the report was updated with the subject accrual completion date, the Bayer regulatory contact information, and one new paragraph at the end of Section 3.
FDA Policy/General
FDA commissioner Scott Gottlieb told Senate appropriators 4/24 that the Trump Administration’s proposed fiscal year 2019 budget increase of $663 million (13%) over last fiscal year will provide the agency with new resources to make “significant investments in advancing critical areas of science, domestic technology and public health.
Drugs
Attorney Jennifer Thomas (Hyman, Phelps & McNamara) says the Supreme Court took steps this week in two False Claims Act (FCA) cases. Writing in her firm’s FDA Law Blog, Thomas says the court first invited the Solicitor General to submit a brief outlining the government’s views on a
Devices
FDA has written to healthcare providers that it is evaluating data suggesting that potentially inaccurate magnetic resonance thermometry information can be displayed during treatment with magnetic resonance-guided laser interstitial thermal therapy devices that are commonly used in neurosurgical procedures. The agency letter says the devices also may not account
Drugs
A new CDER report on developing generic drug transdermal delivery systems (TDS) outlines research efforts under the previous (2012 to 2017) generic drug user fee program and highlights future directions mandated by the current program. FDA has long recognized the special challenges associated with evaluating therapeutic equivalence for generic TDS
Drugs
Public Citizen says its study published in the open access Journal of Clinical Trials finds that using placebos in clinical trials testing new medications for life-threatening diseases for which proven effective treatments already are available can put human subjects at increased risk of harm. A news release (contains link
Drugs
A 10/16-10/20/17 FDA inspection at Lijiang Yinghua Biochemical and Pharmaceutical Co., Lijiang, Yunnan, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (API). A 4/19 Warning Letter said the deviations were: * failing to exercise sufficient controls over computerized systems
Drugs
A 9/4-9/8/17 FDA inspection at Degasa S.A. De C.V., Mexico City, Mexico, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 4/18 Warning Letter. Specific violations noted in the letter were: * failing to have, for each
Drugs
FDA’s Arthritis Advisory Committee has recommended approval of a 2 mg dose of Eli Lilly’s Olumiant (baricitinib), a once-daily oral drug for the treating moderately-to-severely active rheumatoid arthritis for adult patients who have had an inadequate response or intolerance to methotrexate. Panel members unanimously supported
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” The document is intended to provide information to assist sponsors in designing appropriate nonclinical studies for developing such products. It also discusses a streamlined approach to drug development
Drugs
The 2017 CDER Drug Safety Priorities Report lists activities of the Office of Surveillance and Epidemiology (OSE) to carry out its four core functions of pharmacovigilance, pharmacoepidemiology, medication error prevention and analysis, and risk management. The report lists these activities: * Pharmacovigilance/Pharmacoepidemiology – FDA and PatientsLikeMe signed a research collaboration agreement
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Degasa S.A. De C.V. México City, México (4/18): FDA inspected the firm’s drug manufacturing facility 9/2017 and cited significant GMP violations for finished pharmaceuticals.
Devices
Three individuals who marketed and sold over $16 million worth of light-emitting medical devices as a cure-all to consumers have been sentenced by a federal judge in Rapid City, SD. According to the Justice Department, Robert Lytle of Rapid City, who was the leader and organizer of the
Drugs
FDA has released a draft guidance on “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” The document is intended to assist sponsors with designing nonclinical studies for such products, particularly with avoiding unnecessary use of animals. It also discusses a streamlined nonclinical program compared to programs for
Drugs
Federal Register notice: FDA has made available a draft guidance entitled “Opioid Dependence: Developing Depot Buprenorphine Products for Treatment.” The document addresses drug development and trial design issues with studies evaluating depot buprenorphine products (i.e., modified-release products for injection or implantation). To view the notice, click here.
Drugs
FDA has cleared Viz.ai, Inc.’s Viz CTP image processing software to view and analyze functional and dynamic CT perfusion images. The software joins Viz.ai’s technology suite, which includes automated large vessel occlusion (LVO) stroke identification, stroke triage and LVO notification, patient selection, HIPAA compliant communication, mobile
Drugs
FDA has approved a Medtronic PMA for In.Pact Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions up to 360mm in patients with peripheral artery disease. The device’s approval was based on clinical data from the In.Pact Global Study in-stent restenosis and chronic total
Drugs
FDA has sent Pfizer a complete response letter on its BLA for the company’s proposed trastuzumab biosimilar, a copy of Genentech’s Herceptin, indicated for treating patients with breast or metastatic stomach cancer (gastric or gastroesophageal junction adenocarcinoma) whose tumors over-express the HER2 gene. In the letter, the
Devices
Fresenius-Kabi USA has begun a mandatory software update field action for the DXT Relay 2.x because of issues identified in the software that cause it to malfunction. The issues impact the ability of procedure data to be transmitted from a collection device to the customer's electronic
FDA Policy/General
Fresenius has decided to walk away from its planned purchase of Akorn Pharmaceuticals for $4.3 billion after Akorn reportedly failed to “fulfill several closing conditions.” In a statement, Fresenius said there were “material breaches” of data integrity requirements that were supposed to be reported to FDA. Laborie Medical has