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The Consumer Healthcare Products Association (CPHA) says that while it agrees with several principles underlying an FDA draft guidance on content of premarket submissions for managing medical device cybersecurity, there are several elements that should be clarified.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
FDA Policy/General
Clinical Trial Enrichment Strategies Guide Federal Register notice: FDA makes available a final guidance entitled “Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products.” 03/15/2019 Guide on Hematologic Disorders Drug Development Federal Register notice: FDA makes available a final guidance entitled
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Enrichment Strategies for Clinical Trials to Support Demonstration of Effectiveness of Human Drugs and Biological Products.” The document provides several types of enrichment strategies and examples of potential clinical trial designs. It also discusses potential regulatory considerations when using
FDA Policy/General
Federal Register notice: FDA made available a final guidance entitled “Severely Debilitating or Life-Threatening Hematologic Disorders: Nonclinical Development of Pharmaceuticals.” The document outlines nonclinical studies recommended for developing pharmaceuticals used to treat patients with such disorders and addresses comments received to the docket. It is intended to streamline product
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “A Risk-Based Approach to Monitoring of Clinical Investigations: Questions and Answers.” The document provides information to sponsors on risk-based approaches to monitoring of investigational studies of human drug and biological products, medical devices, and product combinations. It
FDA Policy/General
Federal Register notice: FDA has made available a final guidance on “Medical Devices Containing Materials Derived from Animal Sources (Except for In Vitro Diagnostic Devices).” The document updates agency policy on using animal-derived material in medical device manufacturing. It says that animal-derived materials may carry a risk of
FDA Policy/General
[Commentary by Jim Dickinson] Aviation experts have been quick to point out a cause of Boeing’s current crisis that’s been in plain sight ever since Ronald Reagan deregulated the industry and spread that success through the rest of the government – including FDA. In a word: Coziness. Regulated industries