Drugs
New York pharmacist Ira Gross and his shell company, Chaparral Services, were found guilty in state court of distributing HIV medication illegally obtained from the black market to patients. Gross faces a state prison sentence of up to twenty-five years, according to the NY State Attorney General’s office.
Drugs
A Utah federal court has granted summary judgment to Biogen Idec and Elan, dismissing a negligence case brought against them by a man whose wife died from progressive multifocal leukoencephalopathy (PML) after being prescribed Tysabri (natalizumab) for her multiple sclerosis. The suit claimed negligence, negligent failure to warn, and negligent
Drugs
FDA says that PharmaTech has expanded its 7/16 recall to include all liquid products due to possible Burkholderia cepacia contamination. The products were manufactured in the firm’s Davie, FL, facility, the agency says, and were distributed and labeled by six firms. The initial recall announcement covered all non-
Drugs
AstraZeneca has reported disappointing results from a Phase 3 trial (SELECT-1) of its MEK 1/2 inhibitor, selumetinib, in combination with docetaxel chemotherapy as second-line treatment in patients with KRAS mutation-positive locally-advanced or metastatic non-small cell lung cancer. “The results showed that the trial did
Devices
FDA has cleared a Centric Medical 510(k) for the Hammertoe Correction System. The device offers a dual threaded design and is inserted between the proximal and middle phalanges, so that the opposing threads fixate on the phalangeal canal of the toe and compress the joint, according to the company.
Drugs
FDA has accepted for priority review two Marathon Pharmaceuticals NDAs for the investigational drug deflazacort — one for an immediate-release tablet formulation and the other for an oral suspension formulation — for treating patients with Duchenne muscular dystrophy (DMD). The submissions are expected to receive a user fee review target date
Drugs
Attorneys John Hillebrecht and Rebecca McKnight (DLA Piper) say that after years of Justice Department focus on off-label promotion, kickbacks, and false claims, it appears that the focus may be shifting to current good manufacturing practice issues, especially data integrity. Writing in an online post, the two cite a
Drugs
CDER Division of Nonprescription Drug Products deputy director Karen Mahoney says that FDA is taking steps to assist potential sponsors in submitting applications for an OTC form of naloxone, the prescription drug that can stop or reverse the effects of an opioid overdose. Writing in an FDA Voice blog post,
Drugs
CDER has decided to scrap its 2015 new draft guidance on Request for Quality Metrics, and it plans to replace it with a revised draft document later this year on Submission of Quality Metrics Data. “After carefully considering the numerous technical and regulatory comments received to the docket for the
Devices
Medical Compression Systems has obtained 510(k) clearance for its new comprehensive monitoring application, in combination with ActiveCare, a device used for preventing deep vein thrombosis prevention in total joint patients. The online platform is equipped with Bluetooth to allow wireless data transmission between patients and their healthcare providers.
FDA Policy/General
Federal Register Notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget under the Paperwork Reduction Act of 1995 including information on dispute resolutions, SPF labeling, and generic drug user fee cover sheets. To view this notice, click here.
FDA Policy/General
Federal Register Notice: FDA’s Anesthetic and Analgesic Drug Products Advisory Committee and the Drug Safety and Risk Management Advisory Committee will meet 10/5 from 8 a.m. to 5 p.m. at the FDA White Oak Campus, 10903 New Hampshire Ave., Bldg. 31 Conference Center, the Great Room
Drugs
FDA has ordered a partial clinical hold on an Adaptimmune Therapeutics planned pivotal study of NY-ESO SPEAR T-cell therapy in myxoid round cell liposarcoma. This trial is not yet active at any investigational sites, and has not recruited any patients, according to the company. The hold was issued
Drugs
An 8/3-8/5/15 FDA inspection at Concept Products Limited, Tianjin, China, identified significant violations of current good manufacturing practice regulations for finished pharmaceuticals, according to a 7/26 Warning Letter. Specific violations observed during the inspection included: * failing to have, for each batch of drug product, appropriate
FDA Policy/General
A study focused on medical device company representatives in surgical suites says there are “ethical questions about the reliance of surgeons on device reps and device companies for education and surgical assistance and practical concerns regarding existing levels of competence among OR personnel.” The research was reported in the open-
Drugs
A 2/1-2/16 FDA Bioresearch Monitoring Program inspection at North Hills Medical Research, North Richland Hills, TX, found that Dr. John Gabriel did not adhere to applicable statutory requirements and FDA regulations governing the conduct of clinical investigations and the protection of human subjects by failing to ensure
Devices
FDA has approved a Boston Scientific PMA for the Emblem MRI Subcutaneous Implantable Defibrillator (S-ICD) System, as well as magnetic resonance (MR) conditional labeling for all previously implanted Emblem S-ICD Systems. “Now with FDA approval, patients receiving the Emblem MRI S-ICD System, as well as patients who
Drugs
Presumably tired of waiting for FDA to make sense of its position on off-label promotion given many First Amendment losses in the courts, Pharmaceutical Research and Manufacturers of America (PhRMA) and the Biotechnology Innovation Organization (BIO) have issued their own industry practice principles on off-label communications. Attorney James
FDA Policy/General
The U.S. Court of Appeals for the Ninth Circuit may be re-evaluating how it reviews summary judgments in Freedom of Information Act (FOIA) cases. An 8/3 notice granted an en banc hearing in Animal Legal Defense Fund vs. FDA, but provided no explanation why it was rehearing
Drugs
Alkermes has filed a supplemental NDA for a two-month dosing interval for Aristada (aripiprazole lauroxil) extended-release injectable suspension for treating schizophrenia. FDA approved the drug last year as the first long-acting atypical antipsychotic with once-monthly and once-every-six-weeks dosing options, according to the company.
FDA Policy/General
Today FDA posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Adamson Analytical Laboratories, Inc. Corona, CA (8/2). Inspected 8/4-14/15. CGMP deviations, adulterated: The high performance liquid chromatography (HPLC) and gas chromatography (GC) data acquisition systems
FDA Policy/General
Federal Register Notice: FDA will hold a meeting of the General and Plastic Surgery Devices Panel of the Medical Devices Advisory Committee 9/20-21, from 8 a.m. to 6 p.m. at Hilton Washington, DC North/Gaithersburg, Grand Ballroom, 620 Perry Pkwy., Gaithersburg, MD. The committee will discuss