Drugs
University of Ottawa law professor Amir Attaran has suggested that the Canadian government should look at suspending U.S. drug patents as the Trump Administration turns up the heat on its trade dispute with Canada. The U.S. holds more pharmaceutical patents and other intellectual property licenses than any other
FDA Policy/General
Federal Register notice: FDA has established a public docket to receive information, recommendations, and comments on matters related to its publication of technical specifications for the specific use of data standards in drug/biologic submissions. To view the notice, click here.
Drugs
Federal Register notice: FDA is announcing an opportunity for public comment on an information collection extension for the agency guidance entitled “Formal Meetings Between the FDA and Biosimilar Biological Product Sponsors or Applicants” (OMB Control Number 0910–0802). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” The document notes that there is an unmet medical need among EB patients due to the paucity of effective treatment options. To view the notice, click here.
Drugs
FDA has issued Ortho Dermatologics a complete response letter on its NDA for Duobrii (halobetasol propionate and tazarotene) lotion and its use in treating plaque psoriasis. The letter did not cite any deficiencies related to the product’s clinical efficacy or safety, and only noted questions regarding pharmacokinetic data, according
FDA Policy/General
Class 2 for Prostate Tissue Jet System Federal Register notice: FDA classifies the fluid jet system for prostate tissue removal into Class 2 (special controls). 06/15/2018 Draft Guide on Certain Guidewire Submissions Federal Register notice: FDA makes available a draft guidance entitled “Coronary, Peripheral, and Neurovascular Guidewires — Performance
Drugs
FDA has made available a guidance entitled “Epidermolysis Bullosa (EB): Developing Drugs for Treatment of Cutaneous Manifestations.” The document focuses on drug development and trial design issues specific to treating EB, including FDA’s current thinking on endpoint considerations. It notes that there is “not yet sufficient clinical trial precedent
FDA Policy/General
Federal Register notice: FDA has classified the fluid jet system for prostate tissue removal into Class 2 (special controls). The agency has identified it as a prescription device intended for the resection and removal of prostatic tissue for treating benign prostatic hyperplasia. It cuts tissue by using a pressurized jet
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Coronary, Peripheral, and Neurovascular Guidewires — Performance Tests and Recommended Labeling.” The document provides recommendations for the information and testing that should be included in premarket submissions for such devices. To view the notice, click here.
Drugs
FDA has posted an ICH guidance entitled “S9 Nonclinical Evaluation for Anticancer Pharmaceuticals: Questions and Answers.” The document is intended to address challenges sponsors have experienced when implementing recommendations on nonclinical evaluation for anticancer pharmaceuticals. It also encourages reducing, refining and replacing the use of animals in clinical trials.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations.” The document addresses labeling considerations for devices containing lubricious coatings that are used in the vasculature. It also provides recommendations for information to be included in device labeling
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of two Ferring Pharmaceuticals ANDAs because the company notified the agency that they were no longer marketed. The withdrawn products are Menotropins (follicle-stimulating hormone/luteinizing hormone) for injection, 75 IU/75 IU per vial and Menotropins 150 IU/150 IU per vial.
Devices
FDA has approved Medtronic’s 200mm and 250mm lengths of its In.Pact Admiral Drug-Coated Balloon to treat long superficial femoral artery lesions in patients with peripheral artery disease. Approval was based on clinical data from the complex lesion imaging cohorts of the company’s In.PACT Global Study,
Devices
FDA has posted a guidance on “Logical Observation Identifiers Names and Codes for In Vitro Diagnostic (IVD) Tests.” FDA notes that with the use of electronic health records (EHR), there has been a greater demand to standardize the way that IVDs are coded. The document discusses how laboratories commonly associate
Drugs
Public Citizen says the Senate Judiciary Committee “threw a punch for affordable prescriptions” 6/14 by voting to advance the CREATES Act that would prevent branded drug manufacturers from abusing regulatory rules to deny generic and biosimilar manufacturers access to product samples. “Corporations have long used this practice to delay
Devices
Members of the FDA Circulatory System Devices Advisory Committee voted 11-4 on 6/12 to recommend that the agency give premarket approval to Cordis’ Incraft stent-graft device for abdominal aortic aneurysms. FierceBiotech reports that the device is deployed through the artery and opened to seal and relieve pressure
Drugs
FDA has published a draft guidance, Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis, to give sponsors clinical and non-clinical recommendations specific to developing systemic drug products, with a focus on long-acting systemic drug products regulated within CDER for preventing sexually acquired HIV-
Drugs
FDA says the manufacturers and labelers of 11 drug products that contain isometheptene agreed to comply with a 10/12/17 agency order to stop distributing their isometheptene mucate-containing drug products as of 1/1/18. An agency notice says the affected products contain either isometheptene mucate, discloralphenazone, and
Devices
FDA has issued a draft guidance, Intravascular Catheters, Wires, and Delivery Systems with Lubricious Coatings—Labeling Considerations, with recommendations for information to be included in the device labeling submitted in PMAs or 510(k)s for Class 3 and 2 devices containing lubricious coatings used in the vasculature to enhance
Devices
FDA has issued a draft guidance, Coronary, Peripheral, and Neurovascular Guidewires—Performance Testing and Recommended Labeling, to assist industry in designing and executing appropriate performance testing to support a premarket notification. It also provides recommendations for content and labeling to include in 510(k) submissions. When final, the document will
FDA Policy/General
Federal Register notice: FDA has classified brain trauma assessment tests into Class 2 (special controls). The devices are identified as those comprising reagents used to detect and measure brain injury biomarkers in human specimens. The measurements aid in the evaluation of patients with suspected mild traumatic brain injury in conjunction
FDA Policy/General
Federal Register notice: FDA has classified the endoscopic electrosurgical clip cutting system into Class 2 (special controls). The agency has identified it as a prescription device that applies electrical energy to fragment metallic clips, which are devices placed in the digestive tract to close gastrointestinal perforations, hemorrhages, or perform resection.