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The Consumer Healthcare Products Association (CPHA) says that while it agrees with several principles underlying an FDA draft guidance on content of premarket submissions for managing medical device cybersecurity, there are several elements that should be clarified.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
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
Devices
FDA has cleared an Atreon Orthopedics 510(k) for the Rotium Bioresorbable Wick, intended for use in supporting healthy tendon regeneration related to rotator cuff injuries. The synthetic bioresorbable scaffold is designed to be positioned between the repaired tendon and the bone and acts to facilitate and enhance the healing
Devices
The FDA Neurological Devices Panel will be asked to comment 3/21on clinical data submitted in a Neuronix PMA for NeuroAD that did not meet its primary efficacy point in a pivotal trial. The device is proposed as an adjunctive treatment for mild to moderate dementia of the Alzheimer’s
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
Devices
FDA has cleared a Via Surgical 510(k) for the FasTouch Absorbable Fixation System, which features automated lockable surgical mesh fixation. The device is intended to attach prosthetic material to soft tissues in various surgical procedures such as hernia repairs. “Our data clearly demonstrates that a lockable solution is more
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
Devices
FDA has cleared an Intuitive 510(k) for the da Vinci SP robotic surgical system for use in certain transoral otolaryngology procedures in adults. FDA cleared the single port approach for lateral oropharyngectomy procedures (also referred to as radical tonsillectomy) and tongue base resection. The device includes three, multi-jointed,
FDA Policy/General
FDA commissioner Scott Gottlieb’s departure next month leaves a full plate of new initiatives and policy directives he spearheaded in the almost two years he was at helm, and it is natural to wonder which will fall through the cracks once he leaves. One prediction has the agency staying
Devices
Cook Medical has begun recalling (Class 1) one lot of the Transseptal Needle due to a manufacturing error that resulted in some needle tips missing the back bevel that creates a sharp tip. “Without a back bevel, the needle tip could damage the inside of the introducer sheath during insertion
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
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Medical Devices: Use of Symbols in Labeling — Glossary to Support the Use of Symbols in Labeling” (OMB Control Number 0910-0740). The collection follows a 2016 final rule that allows the optional use in medical device labeling
FDA Policy/General
FDA’s medical product programs appear to benefit most from the Trump Administration’s proposed 7% boost ($419 million) to the agency’s 2020 budget (see earlier story). According to a just-released budget justification document for FDA, the budget request for medical product safety- and availability-related programs totals