Drugs
The Federal Trade Commission (FTC) says it has sent warning letters to three unnamed companies that sell oils, tinctures, capsules, “gummies,” and creams containing cannabidiol (CBD), a chemical compound derived from the cannabis plant. The letters tell the companies that it is illegal to advertise that a product can prevent,
Devices
The Metrix Co. (Dubuque, IA) has recalled several lots of its empty IV flexible containers (bag) marketed under the Metrix Secure EVA Dual Chamber and Baxter ExactaMix names, due to the potential for leakages from the IV bag at the chamber divider rod, which could result in a serious infection
Drugs
Pfizer says it supports FDA’s recommendations for general principles to consider when drafting the drug and abuse and dependence section of prescription drug labeling and the information that should be included. Responding to an FDA draft guidance on the subject, the company says that it finds the standard language
Drugs
Public Citizen says H.R. 3, the House Democratic leadership’s bill to lower prescription drug prices, should be improved and then passed. In a statement responding to a Bloomberg News publication of a leaked version of the bill, the advocacy group says it is an “ambitious plan” that “if
Drugs
While post-marketing drug studies should be completed as quickly as possible, there are some studies that simply take a long time to get right. That’s the view of Forbes healthcare contributor John LaMattina in an online post. He reports that most post-marketing studies are completed in four
Drugs
A Dutch physician has sued FDA in Idaho federal court after the agency seized several international packages containing abortion drugs that were addressed to women who were prescribed them. The physician, Rebecca Gomperts, is located in Amsterdam, and she uses a Web site called Aid Access to prescribe and complete
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Medical Devices; Use of Symbols in Labeling — Glossary To Support the Use of Symbols in Labeling” (OMB Control Number 0910-0740). The collection supports an FDA final rule revising medical device and certain biological product labeling regulations
Drugs
A 3/11-3/15 FDA inspection at Enprani Co., Seoul, South Korea, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. An 8/15 Warning Letter says specific violations were: * failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to
Drugs
CluePoints says that it and FDA have extended until 10/21 their cooperative research and development agreement (CRADA) that is exploring a data-driven approach to selecting clinical trial sites “which exhibit data anomalies indicative of fraud, misconduct or sloppiness.” Under the CRADA, FDA and CluePoints have developed and tested
FDA Policy/General
Federal Register notice: FDA has withdrawn approval of 25 NDAs from multiple applicants after they notified the agency that the drug products were no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Acceptance Review for De Novo Classification Requests.” The document explains the procedures and criteria FDA intends to use in assessing whether a request for an evaluation of automatic Class III designation (De Novo classification request or De Novo request)
FDA Policy/General
Federal Register notice: FDA has announced its adoption of the most current set of the Unified Code for Units of Measure (UCUM) codes. The UCUM is a terminology standard that contains a system of coding units of measure used in science and medicine. UCUM offers a single coding system for
FDA Policy/General
Senator Richard Durbin (D-IL) has written FDA acting commissioner Ned Sharpless urging him to take immediate and decisive action to curb the e-cigarette and vaping epidemic that threatens young adults and children in the U.S. or resign. In a 9/6 letter, Durbin said that as acting
FDA Policy/General
FDA is just weeks away from announcing a new plan to modernize its technology infrastructure to help it keep pace with the evolving tech landscape in product development and surveillance. Addressing a Reasearch!America conference in Washington, DC 9/6, acting commissioner Ned Sharpless said an improved information technology platform
Drugs
FDA has denied a 3/21 citizen petition from advocacy group Public Citizen that urged the agency to immediately impose a moratorium on approval of any new or reformulated opioids. The petition said that in the past two decades, and most recently on 11/2/18, FDA has approved new
Devices
FDA has issued two guidances related to medical device de novo classification requests. The first guide, “FDA and Industry Actions on De Novo Classification Requests: Effect on FDA Review Clock and Goals,” describes·different FDA actions that may be taken on De Novo requests and the effect each action has
FDA Policy/General
FDA 9/9 has issued a Warning Letter to Juul Labs over marketing unauthorized modified risk tobacco products by “engaging in labeling, advertising, and/or other activities directed to consumers, including a presentation given to youth at a school.” The agency also sent a letter to the company requesting more
Drugs
FDA says it is developing guidance on data quality issues that pertain to real world data and related study design considerations. Writing in a 9/6 Clinical Journal of the American Society of Nephrology perspective piece, two CDER Division of Cardiovascular and Renal Products officials, Aliza M. Thompson and Mary
Drugs
A new Government Accountability Office (GAO) report finds that FDA has ongoing efforts to help drug manufacturers identify the circumstances under which they could broaden clinical trial eligibility criteria to include patients who are commonly excluded, such as pediatric patients and patients with impaired liver and kidney function, without compromising
FDA Policy/General
Federal Register notice: FDA has determined the regulatory review period for patent extension purposes for GlaxoSmithKline Biologicals’ Shingrix (zoster vaccine recombinant, adjuvanted), a vaccine indicated for preventing herpes zoster (shingles) in adults aged 50 years and older. The review period is 3,257 days, which includes 2,892 days that
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Humanitarian Device Exemption (HDE) Program.” The document explains the criteria FDA considers to determine if “probable benefit” has been demonstrated as part of the Agency’s decision-making process regarding marketing authorization for a humanitarian use device. The guidance
FDA Policy/General
Federal Register notice: FDA has announced that it accepted a priority review voucher to approve AbbVie’s Rinvoq (upadacitnib) on 8/16. The once-daily oral Janus kinase inhibitor is indicated for treating adults with moderately to severely active rheumatoid arthritis who have had an inadequate response or intolerance to