FDA Policy/General
The Western District of Arkansas federal court has ordered J and L Grocery (Alma, AR) to stop distributing drug products, medical devices, cosmetics and food until the company complies with FDA requirements listed in a consent decree. “According to the amended complaint, J and L Grocery held FDA-regulated products
Drugs
A Milwaukee Journal Sentinel investigative report says that of 21 biologic drugs approved by FDA, 62% (13 drugs) have received an agency Boxed Warning. In the majority of those cases, the Boxed Warning was added when new problems were identified after the drug went on the market. The lengthy report
Drugs
A Congressional Budget Office (CBO) analysis of S. 1895, the Lower Health Care Costs Act, sponsored by Sen. Lamar Alexander (R-TN), says that provisions in the measure would allow some generic or biosimilar drugs to enter the market earlier. The analysis says the bill has several provisions that would
Devices
AdvaMed says an FDA draft guidance on review and update of device establishment inspection processes and standards “should be risk-based and consider the participation of the subject company in international device audit programs.” The trade association’s 5/28 comment letter also recommends that the draft guidance include criteria
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Medical Device User Fee Cover Sheet, Form FDA 3601” (OMB Control Number 0910-0511). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Guidance on Reagents for Detection of Specific Novel Influenza A Viruses — 21 CFR Part 866” (OMB Control Number 0910–0584). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has released a draft guidance entitled “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications (Revision 7).” The document outlines certain circumstances where FDA may determine that a short-term waiver from electronic common technical document submission
Drugs
FDA has issued a draft guidance, Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues, with the agency’s current recommendations for an overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone analogues for treating advanced prostate cancer. The document says that new drug applications for the
Drugs
FDA has approved Merck’s Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Product Jurisdiction: Assignment of Agency Component for Review of Premarket Applications — 21 CFR Part 3” (OMB Control Number 0910-0523). The regulation specifies how FDA will determine the organizational component within the agency assigned to have primary
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should reaffirm and reinforce the statutory distinction between drugs and dietary supplements as established in the Dietary Supplement Health and Education Act of 1994 (DSHEA). Responding to an FDA request for comments on responsible innovation in dietary supplements, PhRMA says that
Devices
Teleflex has recalled its Neonatal ConchaSmart Breathing Circuit with Dual Heated Limb and ConchaSmart Column due to complaints about cracks being observed, prior to use, on the swivel wye adaptors. “Cracks in the adaptor may cause breathing distress because the gas may leak and not reach the patient,” a recall
Devices
FDA has cleared an Integrated Endoscopy 510(k) for Nuvis Single-Use Arthroscope. The battery-operated arthroscope is designed to provide high definition visualization with its proprietary optical design, “while directly addressing key safety and sterility issues associated with traditional, reusable arthroscopes,” the company says. The single-use aspect provides
Biologics
A 2/13-2/25 FDA inspection at the Virginia Center for Reproductive Medicine, Reston, VA, identified significant deviations from the regulations for human cells, tissues, and cellular and tissue-based products. A 7/1 Warning Letter says specific deviations were: * failing to test a specimen from an anonymous or
Drugs
A 1/28-2/5 FDA inspection at the Strides Pharma Science drug manufacturing facility in Puducherry, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 7/1 Warning Letter says specific violations were: * failing to establish an adequate quality control unit with the responsibility
Drugs
An FDA Center of Excellence in Regulatory Science and Innovation (CERSI) research study conducted with Yale University and the Mayo Clinic will use the Biofourmis BiovitalsHF mobile platform, starting with a study of patients with heart failure to monitor functional capacity and quality of life to see if greater emphasis
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Focus Groups About Drug Products as Used by the Food and Drug Administration” (OMB Control Number 0910-0677). The agency says focus groups are intended to provide a more in-depth understanding of individuals’ attitudes, beliefs, motivations,
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Electronic Drug Product Reporting for Human Drug Compounding Outsourcing Facilities Under Section 503B of the Federal Food, Drug, and Cosmetic Act” (OMB Control Number 0910-0827). Outsourcing facilities must register with and submit regular reports identifying the
Drugs
FDA has posted a draft guidance as its seventh revision to “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The document describes how sponsors and applicants must organize the content that they submit to the agency electronically for all submission
Devices
FDA has issued a safety alert about potential complications in patients implanted with both programmable cerebrospinal fluid (CSF) shunt systems and some hearing implants that contain magnets, such as cochlear implants, bone conduction hearing devices, or middle ear hearing devices. “Magnetic interactions between these devices may occur when implanted in
Drugs
An 8/17-9/7/18 FDA inspection at the Ecometics drug manufacturing facility in Norwalk, CT, found significant repeat violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 4/16 Warning Letter says specific violations were: * failing to establish and follow adequate written procedures
Drugs
Rep. Mike Kelly (R-PA), a diabetic and member of the Congressional Diabetes Caucus, is asking FDA for information on issues that may have contributed to it not listing insulin as a peptide drug product eligible for generic production in ANDA guidance issued 10/2017. In a 7/16 letter