FDA Policy/General
The research proposed by CDER’s Office of Prescription Drug Promotion into celebrity endorser status and explicitness of payment in a direct-to-consumer promotion will likely reflect the opinions of a younger, female-skewed population, according to Duke University’s SciReg Lab in a 3/30 comment letter. The
Drugs
AdvaMed says it is proposing minor revisions to improve the clarity and impact of an FDA draft guidance on bridging for drug-device and biologic-device combination products. The association’s comment letter says AdvaMed stands ready to assist the agency in finalizing the guidance and developing additional policies that
Drugs
The Trump administration continues to put pressure on FDA to speed access to potential coronavirus treatments. The latest effort has the White House supporting a decades-old flu drug to be used as a possible Covid-19 treatment. Politico reports that the drug, Fujifilm’s Avigan, has been touted by
Drugs
An 8/12-9/6/19 FDA inspection at Bulletproof 360, Seattle, WA, found serious violations of current good manufacturing practice (CGMP) regulations for dietary supplements, as well as other violations. A 3/20 Warning Letter says the agency determined that some of the firm’s supplements are considered to
Biologics
An FDA Office of Bioresearch Monitoring Operations 6/24-6/28/19 inspection at Steiner Biotechnology, Henderson, NV, found “objectionable conditions” related to the firm’s participation in nonclinical Good Laboratory Practice studies concerning the Skeletal Graft and Ridge Graft. A just-released 2/3 Warning Letter says specific deviations
Devices
FDA says it is proposing to reclassify two types of hepatitis C virus (HCV) diagnostic tests from Class 3 to Class 2. If the reclassification is finalized, devices of that type could go through the 510(k) pathway instead of the PMA pathway, an agency notice says. As Class 2
FDA Policy/General
Federal Register notice: FDA is amending certain medical device regulations to accurately reflect the devices exempted from premarket notification (510(k)) as indicated in lists published on 4/13/2017 and 7/11/2017. The agency says the revisions are necessary to correct editorial errors to ensure that the codified
Drugs
FDA is asking manufacturers to withdraw all prescription and over-the-counter ranitidine (Zantac and generics) products from the market immediately due to NDMA contamination that can increase over time. An agency news release says FDA has determined that the N-Nitrosodimethylamine impurity in some ranitidine products increases over time
Devices
Medtronic has recalled (Class 1) its Pipeline Flex Embolization Device and Pipeline Flex Embolization Device with Shield Technology because there is a risk the delivery system could fracture while placing the stent inside a patient. “Fractured pieces of the delivery system could be left inside the patient’s brain bloodstream,
Devices
FDA has issued an emergency use authorization for the NeoMoDx SARS-CoV-2 assay running on the NeuMoDx molecular systems. The company says the assay is a rapid, automated, in vitro real-time diagnostic test for the direct detection of SARS-CoV-2 coronavirus RNA from nasopharyngeal, oropharyngeal, and nasal
FDA Policy/General
Federal Register notice: FDA has made available a guidance entitled “Notifying FDA of a Permanent Discontinuance or Interruption in Manufacturing Under Section 506C of the FD&C Act.” The document discusses requirements for manufacturers to provide FDA timely, informative notifications about changes in the production of certain drugs and
FDA Policy/General
Federal Register notice: FDA has announced a 6/8 Ophthalmic Devices Panel of the Medical Devices Advisory Committee meeting. Panel members are set to review a Refocus Group PMA for the VisAbility Micro Insert, indicated for bilateral scleral implantation to improve unaided near vision in phakic, presbyopic patients between the
Drugs
A 9/2-9/5/19 FDA inspection at Ficosota, Ltd., Shumen, Bulgaria, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 2/28 Warning Letter says specific violations were: * failing to have, for each batch of a drug product, appropriate laboratory determination
Drugs
An 8/22-8/27/19 FDA inspection at Trilogy Laboratories, Fort Myers, FL, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals and other violations. A just-released 3/5 Warning Letter says specific violations were: * failing to perform, for each batch of a drug
Drugs
Board-certified psychiatrist David Behar, who says he has hundreds of former and dozens of current clozapine patients, is asking FDA to decommission the antipsychotic clozapine REMS program and allow healthcare professionals to rely on clinical judgment for treating and monitoring clozapine patients. Behar’s 3/9 petition specifically asks
Drugs
An 8/29-9/6/19 FDA inspection at Pfizer Healthcare India Private Limited, Andhra, Pradesh, India, found a significant violation of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/25 Warning Letter says the firm failed to thoroughly investigate any unexplained discrepancy or failure of a
Devices
CME America has recalled the BodyGuard Infusion Pump Systems because they may under or over infuse medications. The reason for the infusion errors is not known, a recall notice says. Using an affected infusion pump may cause serious adverse health consequences including death, it says. To date, there have been
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says the topics discussed at the FDA 2/24 Rare Disease Day public meeting were “valuable in generating a shared understanding of the issues facing manufacturers in rare disease drug development, especially regarding the use of natural history studies and registry data.” The
Drugs
FDA will not penalize Novartis for submitting manipulated test results tied to its Zolgensma gene therapy last year. BioPharma Dive reports online that the violations were documents in an 8/2019 inspection of the company’s AveXis unit that led to the dismissal of two AveXis senior executives. FDA had
Drugs
Nevada’s federal court has ruled that six Amarin patents on its Vascepa (icosapent ethyl) heart drug are “obvious” and thus invalid, clearing the way for two generic companies to continue to pursue their ANDAs. Reuters reports that Amarin said it will try to prevent the launch of a generic
Drugs
FDA says it has created a special emergency program for possible Covid-19 therapies. An online agency statement says the Coronavirus Treatment Acceleration Program (CTAP) “uses every available method to move new treatments to patients as quickly as possible, while at the same time finding out whether they are helpful
Drugs
FDA has accepted a Bristol Myers Squibb and Bluebird Bio BLA for idecabtagene vicleucel, a B-cell maturation antigen (BCMA)-directed chimeric antigen receptor (CAR) T cell immunotherapy for treating adult patients with multiple myeloma who have received at least three prior therapies, including an immunomodulatory agent, a proteasome inhibitor