FDA Policy/General
FDA says the iMedDo Web site takes orders for NeuSilver Colloidal Silver and NeuKids lower dose silver for pets and children. A just-released 2/19 Warning Letter gives examples of Web site claims that provide evidence that the products are intended for use as drugs. Since the products are
Drugs
FDA has approved a Clarus Therapeutics NDA for Jatenzo (testosterone undecanoate), an oral testosterone capsule to treat men with certain forms of hypogonadism. An FDA release says that the product is intended for men having low testosterone levels due to specific medical conditions, and should not be used to treat
Devices
FDA has cleared an Innovative Neurological Devices 510(k) for the Cervella Cranial Electrotherapy Stimulator for treating anxiety, depression, and insomnia. The device works by delivering micro pulses of electrical current across a patient’s brain. The company says that clinical studies have demonstrated that the electrical stimulation results in
Devices
For the first time in over 20 years of regulating mammography facilities, FDA is proposing amendments to regulations to help improve the quality of mammography services. An agency news release says the changes would “expand the information mammography facilities must provide to patients and healthcare professionals, allowing for more informed
Drugs
A 3/6-3/15/18 FDA inspection at Thibiant International, Newbury Park, CA, found significant violations of current good manufacturing practice (CGMP) regulations in its production of finished pharmaceuticals. A 3/6 Warning Letter says the specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Biologics
Janssen Pharmaceutical has submitted a supplemental BLA seeking approval of Darzalex (daratumumab) in combination with bortezomib, thalidomide and dexamethasone for newly diagnosed patients with multiple myeloma who are eligible for autologous stem cell transplant. The submission is based on data from the Phase 3 CASSIOPEIA (MMY3006) clinical study, which Janssen
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Clinical Laboratory Improvement Amendments (CLIA) of 1988 Waiver Applications.” CLIA requires that clinical laboratories obtain a certificate from HHS before accepting materials derived from the human body for laboratory tests. Laboratories that perform only tests that are
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Standards Development and the Use of Standards in Regulatory Submissions Reviewed.” The document provides CBER recommendations on the use of standards in product development and control as well as the use of such standards in CBER’s managed review
Devices
A 3/14 CDRH Webinar discussed the 2/5 final guidance on concepts and principles of the “least burdensome” regulatory information provisions. CDRH Office of Device Evaluation regulatory advisor Joshua Silverstein said the guidance describes the agency’s use of the least burdensome approach through medical device regulation to remove
Biologics
FDA commissioner Scott Gottlieb and CBER director Peter Marks say the agency is seeking better safety measures to mitigate potential risks to blood products. In a joint statement, they say that technology exists to potentially transform the assurance of blood product safety while also potentially reducing the cost. Whether an
Devices
Public Citizen Health Research Group founder and senior advisor Sidney Wolfe says FDA should require extensive pre-approval testing of permanent implantable devices, including breast implants. Addressing the agency’s General and Plastic Surgery Device Panel 3/26, Wolfe said breast implants have caused many serious medical conditions in women,
Drugs
FDA has cleared an InControl Medical 510(k) for the Attain, described by the company as the first over-the-counter non-implantable muscle stimulator designed for at-home use to help treat women suffering with stress, urge, mixed urinary incontinence or bowel incontinence. The device provides a guided exercise
Devices
FDA has cleared a Masimo 510(k) for the Rad-67 Pulse CO-Oximeter with Spot-check Next Generation SpHb monitoring technology and the rainbow DCI-mini Reusable Sensor. Rad-67 offers hemoglobin measurement (SpHb) and Measure-through Motion and Low Perfusion SET pulse oximetry, the company says. The device
Drugs
Stakeholders are praising FDA for its draft guidance on developing and submitting proposed draft guidance relating to patient experience data. The Biotechnology Innovation Organization (BIO) says it believes that “strong trilateral communication between FDA, patients and patient organizations, and sponsors around patient experience will result in incorporation of patient experience
Drugs
A 3/19-3/30/18 FDA inspection at the Mariposa Labs drug manufacturing facility in Boise, ID, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 3/14 Warning Letter says the firm also manufactured unapproved and misbranded drug products. Specific CGMP violations noted
Drugs
CDER clinical pharmacologists are helping drug developers use computational models to achieve safe and effective dosing recommendations for patients taking more than one drug. In a Regulatory Science Impact Story, CDER says physiologically based pharmacokinetic models “make it possible to simulate clinical trials that support dosing recommendations, as well as
Drugs
Celgene has submitted an NDA for ozanimod for treating adults with relapsing forms of multiple sclerosis (RMS). Ozanimod is described by the company as an oral, sphingosine 1-phosphate (S1P) receptor modulator, which binds with high affinity selectively to S1P subtypes 1 and 5. The drug causes lymphocyte retention in
Devices
FDA commissioner Scott Gottlieb says the agency is taking steps to prevent and mitigate potential medical device shortages due to the recent closure of an Illinois sterilization facility and the likely closure of a second facility. In a statement, Gottlieb says FDA has been monitoring the situation following action by
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Mariposa Labs Boise, ID (3/14): FDA inspected the firm 3/2018 and cited significant GMP violations for finished pharmaceuticals. The firm was also cited for manufacturing unidentified, unapproved
Biologics
FDA has released a final guidance on “Standards Development and the Use of Standards in Regulatory Submissions Reviewed in the Center for Biologics Evaluation and Research.” The document provides CBER recommendations on the use of standards in product development and control as well as the use of such standards in
FDA Policy/General
Federal Register notice: FDA has announced a 5/8 Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Chiesi USA NDA for mannitol inhalation powder, indicated for managing cystic fibrosis to improve pulmonary function in patients 18 years of age and older in conjunction with standard
Devices
FDA has cleared a SpineEX 510(k) for its Sagittae Lateral Lumbar Interbody (LLIF) Fusion System. The company describes the device as a personalized, adjustable expandable LLIF device designed to minimize impaction, maximize indirect decompression, and provide a large graft space optimal for lumbar fusion procedures. It allows for up