Devices
FDA has cleared a Siemens Healthineers 510(k) for the Somatom X.cite premium single-source computed tomography scanner and its myExam Companion user interface. The device works by guiding users through the exam workflow with precise questions about the patient, for example, a patient’s electrocardiogram waveform for a
EIRs/483s
FDA has approved a Medtronic PMA for the In.Pact AV drug-coated balloon, a paclitaxel-coated balloon indicated for treating failing arteriovenous (AV) access in patients with end-stage renal disease (ESRD) undergoing dialysis. Patients with ESRD rely on AV fistulae for hemodialysis, and over time vessel restenosis limits
Drugs
An analysis commissioned by Pharmaceutical Research and Manufacturers of America (PhRMA), the Biotechnology Innovation Organization, and the Council of State Bioscience Associations, warns that H.R. 3, House Democrats’ drug pricing plan, “could result in 56 fewer new medicines over 10 years.” The analysis projects that the bill would cut
Drugs
The World Health Organization (WHO) has released for comment a draft guideline, Guideline on Data Integrity, with information, guidance, and recommendations to facilitate compliance with data integrity and good practices in documentation and record-keeping requirements. The document does not cover medical devices. The WHO says that where possible, the
Drugs
FDA has issued a draft guidance, Transdermal and Topical Delivery Systems—Product Development and Quality Considerations, with recommendations for applicants and manufacturers of transdermal and topical delivery systems regarding the pharmaceutical development and quality information to include in NDAs and ANDAs. The document specifically discusses the agency’s current thinking
FDA Policy/General
Federal Register notice: FDA has established a public docket for interested parties to nominate bulk drug substances or re-nominate bulk drug substances that were previously nominated without adequate supporting information for inclusion on a list of bulk drug substances for compounding certain animal drugs without a patient specific prescription
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance for Industry #256 entitled “Compounding Animal Drugs from Bulk Drug Substances.” The document describes FDA’s current thinking about compounding animal drugs from bulk drug substances. The agency has generally exercised enforcement discretion on animal drug compounding from bulk drug
Devices
An 11/6 CDRH Webinar presented background on the Center’s Safer Technology Program for Medical Devices (STeP) that is part of a draft guidance outlining the agency’s vision for the program. Once finalized, STeP will be a voluntary pathway for certain medical devices that are expected to significantly
FDA Policy/General
FDA commissioner nominee Stephen Hahn sailed through his Senate confirmation hearing 11/20 with praise and some resistance from lawmakers. Senate Health, Education, Labor & Pensions chair Lamar Alexander (R-TN) called Hahn an “impressive choice” to lead FDA. “This is a critical time for FDA, and there is a
FDA Policy/General
Federal Register notice: FDA has announced a 12/13 Dermatologic and Ophthalmic Drugs Advisory Committee meeting. Panel members will discuss a Horizon Pharma Ireland BLA for teprotumumab solution for intravenous use to treat active thyroid eye disease. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has announced a 1/16 Anesthetic and Analgesic Drug Products Advisory Committee meeting. Panel members will discuss a Durect NDA for bupivacaine extended-release solution for instillation for treating post-surgical analgesia. To view the notice, click here.
Devices
FDA has cleared a Carestream 510(k) for its Dual-Energy imaging technology and its Focus 35C Detector with Image Suite Software for medical imaging. The company says the device uses two filter materials that are automatically switched between the high- and low-energy exposures to produce a soft-tissue-
Drugs
Apicore Pharmaceutical Private is asking FDA to require that any ANDA or ANDA supplement for penicillamine capsules be approved only if the bioequivalence study supporting such approval uses a bioanalytical method that stabilizes penicillamine from oxidation as soon as the blood samples are collected and measures copper-bound penicillamine, along
Drugs
In a recent CDER Webinar, Office of Prescription Drug Promotion lead project manager Jason Cober reviewed various types of errors the agency is seeing in promotional submissions in eCTD (electronic common technical document) format. A final guidance on eCTD submission of promotional labeling and advertising materials was issued 6/24.
FDA Policy/General
President Donald Trump apparently is pulling back administration plans to issue new rules on e-cigarettes/vaping to curb youth access. After a 9/11 White House meeting between then-FDA acting commissioner Ned Sharpless, HHS secretary Alex Azar and President Donald Trump, the agency was reportedly moving forward to
Drugs
A 4/15-4/30 FDA inspection at Apothecus Pharmaceutical, Hicksville, NY, found significant violations of current good manufacturing practice (CGMP) regulations for combination products. Specific violations listed in an 11/8 Warning Letter were: * failing to thoroughly investigate any unexplained discrepancy or failure of a batch or any of
Drugs
A 3/11-4/9 FDA inspection at Torrent Pharma, Levittown, PA, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/28 Warning Letter says specific violations were: * failing to use equipment in the manufacture, processing, packing, or holding of drug products that is
Devices
FDA says four reagent kits manufactured and distributed by Carolina Liquid Chemistries Corp., Winston Salem, NC, are adulterated and misbranded. A just-released 7/31 Warning Letter says the firm does not have a 510(k) or PMA for the kits. The letter says the firm distributes the kits with
FDA Policy/General
Federal Register notice: FDA has announced a 12/5 public meeting entitled “2019 Public Meeting on CDER Standard Core Sets: Clinical Outcome Assessments and Endpoints Grant Program.” The meeting is intended to help ensure that the clinical outcome assessments (COAs) and endpoints developed reflect what is most important to patients
FDA Policy/General
FDA has issued a draft guidance, Compounding Animal Drugs from Bulk Drug Substances, to describe agency policy on the compounding of animal drugs from bulk drug substances by or under the direct supervision of veterinarians or licensed pharmacists. The document says FDA has generally exercised enforcement discretion with regard to
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. A.P. Deauville, New Brunswick, NJ (11/8): FDA inspected the firm in April and cited significant GMP violations for finished pharmaceuticals. For example, it failed to thoroughly investigate
Drugs
Reps. David Cicilline (D-RI) and Jerrold Nadler (D-NY) have introduced the Affordable Prescriptions for Patients Through Promoting Competition Act (H.R. 5133) to use the Federal Trade Commission (FTC) to prohibit drug companies from engaging in anticompetitive “product hopping.” Text of the bill is not yet available. In