FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Bayer’s Adempas (riociguat) is 2,394 days for extending a patent which claims the human drug product. Adempas is indicated for treating adults with persistent/recurrent chronic thromboembolic pulmonary hypertension (CTEPH) after surgical treatment or inoperable CTEPH to
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Pfizer’s Apoquel (oclacitinib) for extending a patent which claims the animal drug product. Apoquel is indicated for control of pruritus associated with allergic dermatitis and control of atopic dermatitis in dogs at least 12 months of age. To
FDA Policy/General
Federal Register Notice: FDA has determined the regulatory review period for Genentech’s Gazya is 1,698 for extending a patent which claims the human biological product. Gazyva is indicated, in addition with chlorambucil, for treating patients with previously untreated chronic lymphocytic leukemia. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA is correcting a 3/7 Federal Register notice, which announced a guidance for industry entitled Donor Screening Recommendations to Reduce the Risk of Transmission of Zika Virus by Human Cells, Tissues, and Cellular and Tissue-Based Products. The document was published with an incorrect docket number
FDA Policy/General
Federal Register Notice: FDA is withdrawing approval of an EMD Serono NDA for Luveris (lutropin alpha for injection). The company has voluntarily requested that approval of this application be withdrawn, thereby waiving its opportunity for a hearing. To view this notice, click here.
FDA Policy/General
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Devices
Boston Scientific has recalled (Class 1) all models of its thrombectomy Fetch 2 Aspiration Catheter, used during procedures to remove small blood clots from coronary arteries. The recall is based on complaints about shaft breakage during the procedure, and the broken section was either removed while still partially attached to
Devices
Medtronic says that a Minneapolis Star Tribune investigative report that criticizes the company’s failure for many years to submit an adverse event database on its Infuse bone fusion product “makes insinuations that are false, and fails to include information” regarding the retrospective chart review and company actions. The newspaper
Drugs
A Utah federal court has agreed with Aventis that there was “clear evidence,” as required under Wyeth v. Levine, that FDA would not have approved labeling changes for its Clomid to include a warning against using the drug before pregnancy. The case was brought by a woman who used Clomid
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Miami Fat Supply, Inc. Groveland, FL (3/17). Inspected 10/13-14/15. QSR deviations, adulterated: The firm failed to validate a process whose results cannot be fully verified
Devices
Dexcom has begun a Class 1 recall of its Continuous Glucose Monitoring System G4 and G5 Platinum Receivers because the audible alarm may not activate when low or high glucose levels (hypoglycemia or hyperglycemia) are detected. The devices include a sensor that is placed under the skin to measure blood
Devices
FDA has approved a Biotronik PMA for its BioMonitor 2, a subcutaneously insertable cardiac remote monitor with ProMRI technology. The device is designed to provide physicians with the ability to accurately detect and diagnose atrial fibrillation, ventricular tachycardia and fibrillation, and syncope. It can also be used to monitor atrial
Drugs
Some 15 healthcare stakeholders led by the Generic Pharmaceutical Association and including managed care companies, pharmaceutical benefits managers, and leading drug companies have told FDA that a proposed rule to change generic drug labeling requirements could permit multiple, potentially conflicting labels for therapeutically equivalent products that would create provider and
FDA Policy/General
Federal Register Notice: FDA is making available a guidance for industry entitled Safety Considerations for Product Design to Minimize Medication Errors. The guidance is intended for sponsors of investigational new drug applications; NDAs, BLAs, ANDAs; and manufacturers of prescription drugs marketed without an approved application or over-the-counter monograph
Drugs
FDA’s Oncologic Drugs Advisory Committee 4/12 voted 12 to 1 to not recommend accelerated approval for a Clovis Oncology NDA for rociletinib tablets and its use in treating patients with mutant epidermal growth factor receptor (EGFR) non-small cell lung cancer who have been previously treated with an
FDA Policy/General
Federal Register Notice: The Center for Veterinary Medicine (CVM) is proposing to withdraw approval of NADAs providing for use of carbadox in medicated swine feed. This action is based on CVM’s determination that the use of carbadox under the approved conditions of use results in residues of carcinogenic concern
Drugs
Biosimilar products are unlikely to have federal preemption protection from state product liability claims like generic drugs under PLIVA v. Mensing, according to an analysis by Reed Smith attorney James Beck. Traditional generic preemption “depends on the impossibility of making an immediate change to a product (including its labeling) as
Drugs
Durect Corp. is amending its PERSIST Phase 3 trial for Posimir, an extended-release depot utilizing the company’s SABER technology designed to continuously deliver bupivacaine, based on recommendations in an FDA advice letter. One of the recommendations was to incorporate standard bupivacaine HCl as an active control. “This change
FDA Policy/General
Federal Register Notice: FDA’s proposed collection of information “Medical Device User Fee Cover Sheet, Form FDA 3601,” has been submitted to the Office of Management and Budget for review and clearance under the Paperwork Reduction Act of 1995. To view this notice, click here.
Devices
Vascular Solutions has begun a recall of its Guardian II hemostasis valves (Model Numbers 8210 and 8211) used in catheterization procedures because they pose an increased risk of air leakage that may lead to an air embolism, which could result in serious injury or death. The affected products were manufactured
Biologics
FDA has accepted for priority review a Genentech BLA for atezolizumab for treating patients with locally advanced or metastatic non-small cell lung cancer whose disease expresses the protein PD-L1 (programmed death ligand-1), as determined by an FDA-approved test, and who have progressed on or after platinum-
Drugs
FDA has approved an AbbVie NDA for Venclexta (venetoclax) and its use in treating patients with chronic lymphocytic leukemia (CLL) who have a chromosomal abnormality called 17p deletion and who have been treated with a least one prior therapy. An FDA release says the drug is the first agency-approved