Drugs
The Justice Department says that Patient Services Inc. (PSI) a foundation based in Virginia, has agreed to pay $3 million to resolve allegations that it violated the False Claims Act by acting as a conduit through which some drug companies could provide kickbacks to Medicare patients taking the companies’ drugs
Drugs
Two former Insys executives were sentenced to more than two years in federal prison each for their roles in a bribery and kickback scheme that prosecutors said helped to fuel the opioid crisis. Former national sales director Richard Simon was sentenced to 33 months in prison and former regional sales
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. CGA Limited Laventille, Trinidad & Tobago (12/19): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to test
Drugs
CDER says that the approved restructuring of the Office of New Drugs (OND) created offices that align interrelated disease areas and divisions with clearer and more focused areas of expertise. As a result, an online notice says, the names of the OND offices and divisions have changed. CDER says sponsors
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Radioactive Drug Research Committees—21 CFR 361.1” (OMB Control Number 0910-0053). FDA has authority to establish radioactive drug research committees to approve and monitor basic research studies using radiopharmaceuticals. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Customer/Partner Service Surveys” (OMB Control Number 0910–0360). The collection covers customer/partner service surveys of regulated entities, such as food processors; cosmetic, drug, biologic, and medical device manufacturers; consumers; and health professionals. The request also
FDA Policy/General
Federal Register notice: FDA is requesting that any consumer organizations interested in participating in selecting voting or nonvoting consumer representatives to serve on its advisory committees or panels notify the agency in writing. FDA is also requesting nominations for voting and nonvoting consumer representatives to serve on panels for which
FDA Policy/General
Federal Register notice: FDA has announced a 2/24 public meeting on “FDA Rare Disease Day 2020: Supporting the Future of Rare Disease Product Development.” The meeting is intended to obtain stakeholders’ perspectives on challenges and solutions in rare disease product development and identify commonalities that can support product development
FDA Policy/General
Federal Register notice: FDA is seeking comments on a new information collection entitled “Empirical Study of Promotional Implications of Proprietary Prescription Drug Names.” The study is intended to give FDA insight into improving its proprietary name review that focuses on potential misbranding from names that overstate drug efficacy. To view
FDA Policy/General
CDRH Radiation Safety Panel Seeks Members Federal Register notice: FDA requests nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. 01/17/2020 Info Collection Extension for BLA Licensing Provsions Federal Register notice: FDA submits to OMB an information collection extension for BLA general
FDA Policy/General
DEVICES FDA has cleared a Nanowear 510(k) for its SimplECG, a remote cardiac monitoring undergarment. The device collects continuous multi-channel ECG, heart rate and respiratory rate data from the garment and transfers it to a Web-based portal for review by a physician through a mobile application. FDA
Drugs
FDA is seeking comments on new proposed research by CDER’s Office of Prescription Drug Promotion (OPDP) entitled “Empirical Study of Promotional Implications of Proprietary Prescription Drug Names.” The study is intended to give FDA insight into improving its proprietary name review that focuses on potential misbranding from names that
FDA Policy/General
Federal Register notice: FDA is requesting nominations for members to serve on CDRH’s Technical Electronic Product Radiation Safety Standards Committee. Nominations received after 3/17 will be considered for later vacancies. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “General Licensing Provisions: Biologics License Application, Changes to an Approved Application, Labeling, Revocation and Suspension, Postmarketing Studies Status Reports, and Form FDA 356h” (OMB Control Number 0910-0338). To view the notice, click here.
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) issued 10 enforcement letters in 2019 addressing communications carried in 11 different communications vehicles. Eye on FDA reports that violations were nearly evenly divided between digital communication vehicles (five violations) and traditional vehicles (six violations). Other findings in the analysis: * no single
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Pediatric Study Plans for Oncology Drugs: Questions and Answers.” The document provides information about the submission of an initial pediatric study plan for oncology drugs only. FDA has received a number of questions and the draft addresses the most
Drugs
Attorneys from McDermitt Will & Emery say that in 2019 the CDER Office of Prescription Drug Promotion (OPDP) issued a total of six untitled letters and three Warning Letters, a slight increase over the 2018 total. Writing in their firm’s review of the year 2019 for FDA, they say
FDA Policy/General
Eight FDA staffers say they envision that machine learning will play an increasingly important role in future drug development and regulation. Writing in Clinical Pharmacology and Therapeutics, they say (membership or purchase required) that machine learning “will likely be an essential tool for data aggregation, information synthesis, pattern recognition, and
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Health Pharma USA Rahway, NJ (12/18): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, the company’s quality control unit
FDA Policy/General
Federal Register notice: FDA has exempted powered wheeled stretchers (product code INK) from premarket notification (510(k)) requirements. The devices are battery-powered tables with wheels that are intended for medical purposes for use by patients who are unable to propel themselves independently and who must maintain a prone or
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Peripheral Percutaneous Transluminal Angioplasty (PTA) and Specialty Catheters — Premarket Notification (510(k)) Submissions; Draft Guidance for Industry and Food and Drug Administration Staff.” The document applies to infusion catheters, PTA balloon catheters for in-stent restenosis, and scoring/cutting
FDA Policy/General
Meeting on Asbestos in Talc and Cosmetic Products Federal Register notice: FDA announces a 2/4 public meeting entitled “Testing Methods for Asbestos in Talc and Cosmetic Products Containing Talc.” 01/10/2020 FDA Withdrawing 249 ANDAs Over Annual Reports Federal Register notice: FDA proposes to withdraw approval of 249