Drugs
The DC federal court has granted an FDA motion for a voluntary remand of Vanda Pharmaceuticals’ suit challenging the agency requirement to perform nine-month large animal studies of its tradipitant before beginning studies in humans. (Tradipitant is a potential treatment for several human conditions including gastroparesis). The court declined
FDA Policy/General
Oregon attorney general Ellen Rosenblum says Pfizer will pay $975,000 to settle state charges that it distributed misleading marketing materials and coupons to Oregon consumers. Rosenblum says the coupons were designed to help consumers afford copays or deductibles associated with branded drugs. Some $620,000 of the settlement money
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
Devices
Symantec says the current iteration of an FDA draft guidance on content of premarket submissions for managing cybersecurity in medical devices has “significant improvements over the previous version and helps align stakeholders to the shared mission of providing a more secure and safer healthcare system.” In a comment letter, the
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Pediatric HIV Infection: Drug Product Development for Treatment.” The document provides general recommendations for developing antiretroviral drug products for treating human immunodeficiency virus infection in pediatric patients. It also addresses when to initiate pediatric formulation development and begin pediatric
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
Devices
The National Evaluation System for health Technology (NEST) has test cases underway to demonstrate proof-of-concept for generating robust real-world evidence (RWE) in preparation for regulatory submissions such as label expansions or to meet postmarket surveillance requirements. Writing in a Clinical Pharmacology & Therapeutics commentary, CDRH director Jeffrey
Devices
FDA has cleared a Siemens Healthineers 510(k) for the Mobilett Elara Max mobile X-ray system, which features improved information technology (IT) security as well as secure system integration into a hospital’s IT environment for immediate access to patient data. The system also has an improved design that
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
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Human Immunodeficiency Virus-1 Infection: Developing Systemic Drug Products for Pre-Exposure Prophylaxis.” The document provides sponsors with nonclinical and clinical recommendations specific to developing systemic drug products, with a focus on long-acting systemic drug products (including small
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,
Devices
FDA has issued Warning Letters to two breast implant manufacturers for failing to comply with post-market study requirements included in their premarket approval orders. The studies were to assess the long-term safety and risks of the companies’ silicone gel-filled implants. Warning Letters went to Mentor Worldwide, Irvine,
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
Biologics
FDA has approved a Genentech sBLA for Tecentriq (atezolizumab) for combination use with carboplatin and etoposide (chemotherapy) for first-line treatment of adults with extensive-stage small cell lung cancer. Approval was based on data from the Phase III IMpower133 study, which showed that Tecentriq in combination with chemotherapy helped
Devices
A 10/9-11/2/18 FDA inspection at Integra LifeSciences’ TEI Biosciences unit in Boston, MA, found Quality System Regulation violations in the firm’s manufacturing of collagen-based medical devices used for wound care, soft tissue repair, and reconstruction therapy. A 3/6 Warning Letter says the specific
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
Devices
The Consumer Healthcare Products Association (CPHA) says that while it agrees with several principles underlying an FDA draft guidance on content of premarket submissions for managing medical device cybersecurity, there are several elements that should be clarified. In a comment letter CPHA highlights these points: (1) FDA should clarify the