Drugs
A Shanghai, China business owner has been sentenced in Dallas to 18 months imprisonment and one year of supervised release in connection with a scheme to sell mislabeled dietary supplements. Xu Jia Bao (aka Fred Xu) is the principal of Shanghai Waseta International Trade Co. Ltd., a Chinese firm that
Drugs
HHS’s Centers for Medicare & Medicaid Services (CMS) has submitted to OMB for review 3/18 a proposed rule to require including drugs’ list prices in direct-to-consumer (DTC) advertising. The OMB submission was briefly announced by HHS secretary Alex Azar during a speech to the American Health
Drugs
New York University Tandon School of Engineering researchers say they have engineered nanoscale protein micelles capable of both delivering chemotherapeutic drugs and of being tracked by MRI imaging. A university news release says that as a “theranostic,” the innovation combines diagnostic capability and drug delivery, allow researchers to administer therapy
Drugs
FDA says that to assure patient access to the antihypertensive drug losartan, it will allow certain manufacturers to temporarily distribute losartan containing N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) above the interim acceptable intake limit of 0.96 parts per million (ppm) and below 9.82 ppm until the
Drugs
FDA has approved an Amphastar Pharmaceuticals ANDA for blood thinner enoxaparin sodium injection 300mg/3mL (100mg/mL) multiple dose vials, a generic copy of Sanofi-Aventis’ Lovenox. Amphastar also manufactures and distributes enoxaparin sodium injection in prefilled syringes. Enoxaparin sodium is used to treat and prevent deep vein thrombosis and
Drugs
People for the Ethical Treatment of Animals (PETA) says that following discussions with the advocacy group, Johnson & Johnson and its Janssen subsidiary have changed their policy and will no longer conduct or fund so-called forced swim tests in which mice, rats, and other small animals are placed in
Drugs
CDER senior science advisor for compounding Julie Dohm is leaving the agency to join Covington & Burling in its Washington, DC office, effective 3/29. As the top drug compounding official at the agency, Dohm led compounding activities involving multiple offices throughout the agency. She manages teams that implement legislation,
Drugs
FDA has placed a partial clinical hold on an AbbVie and Roche clinical trial program for Venclexta/Venclyxto (venetoclax) for the investigational treatment of multiple myeloma. The partial clinical hold follows a data review from the ongoing Phase 3 BELLINI trial (M14-031) that showed a higher proportion of deaths
Drugs
FDA has sent a Warning Letter to Nutra Pharma for illegally marketing unapproved products labeled as homeopathic with claims for treating addiction and chronic pain, including pain associated with cancer, diabetes, shingles, fibromyalgia and other serious conditions. “Health fraud scams like these are inexcusable,” FDA commissioner Scott Gottlieb is quoted
Drugs
Mylan has recalled two lots of levoleucovorin injection, 250 mg/25 mL due to the presence of particulate matter that has been identified as copper salts. The particles were discovered during 12-month stability testing, a recall notice says. The lots were manufactured by Alidac Pharmaceuticals Limited and distributed by
Drugs
An FDA 4/2-4/6/18 inspection at the United Exchange drug manufacturing facility in Cypress, CA, and a 4/4-4/6/18 inspection at the company’s facility in Rialto, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/6
Drugs
FDA has issued two final guidances to help product sponsors understand agency thinking about preventive treatments for HIV as well as treatments for pediatric patients with HIV. The first guidance, Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis, gives sponsors nonclinical and clinical recommendations specific
Drugs
UFCW Local 1500 Welfare Fund, that provides health and welfare benefits to some 23,000 grocery workers in New York State, is suing AbbVie in an Illinois federal court alleging that it colluded to divide the market for its Humira between the U.S. and Europe and used a “patent
Drugs
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Integra LifeSciences Plainsboro, NJ (3/6): FDA inspected Integra’s TEI Biosciences facility in Boston 10/2018 and cited GMP violations for its collagen based medical devices. For example,
Drugs
Stokes Healthcare has recalled one lot of veterinary-use pilocarpine 0.1% ophthalmic solution because it has been found to contain a higher level of the preservative benzalkonium chloride than is typical. “Use of this product potentially could result in irreversible dry eye syndrome due to the elevated concentration of
Drugs
FDA has accepted for review an Aimmune Therapeutics BLA for AR101 as a treatment to reduce the risk of anaphylaxis following accidental exposure to peanuts. The agency has set a 12-month review deadline to be completed 1/2020. The company says it has been told that FDA expects to
Drugs
Hospira has recalled three lots of sodium bicarbonate injection USP, 50 mEq/50 mL (1 mEq/mL) due to the presence of particulate matter, which has been confirmed as glass. “The administration of a glass particulate, if present in an intravenous drug, may result in local irritation or swelling in
Drugs
FDA has issued a draft guidance, A Risk-Based Approach to Monitoring of Clinical Investigations Questions and Answers, with guidance on risk-based approaches to monitoring investigational studies of human drugs and biological products, medical devices, and combinations. The document has recommendations on planning a monitoring approach, developing the content
Drugs
FDA has published a guidance, Enrichment Strategies for Clinical Trials to Support Determination of Effectiveness of Human Drugs and Biological Products, to increase the efficiency of drug development and support precision medicine. The document also discusses design options for enrichment strategies and discusses interpretation of the results of studies that
Drugs
Federal Register notice: FDA is seeking comments on an information collection extension for “Current Good Manufacturing Practice (CGMP) for Positron Emission Tomography Drugs” ( OMB Control Number 0910-0667). The CGMP requirements are designed according to the unique characteristics of PET drugs, including their short half-lives, and the fact that
Drugs
FDA has issued a guidance, Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals, to assist sponsors in design of nonclinical studies for development of pharmaceuticals used to treat patients with severely debilitating or life-threatening hematologic disorders (SDLTHDS). The document says it is intended to streamline development
Drugs
FDA has issued Pharmaceutics International two Establishment Inspection Reports (EIRs) following routine and pre-approval inspections last October and November at the company’s non-sterile and sterile drug production facilities in Hunt Valley and Cockeysville, MD. The contract development and manufacturing organization was given “voluntary action indicated” status on