FDA Policy/General
Federal Register notice: FDA is requesting comments on 21 drug substances concerning abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on availability for medical use. The comments will be considered in preparing a response from the U.S. to the World Health Organization to use in
Drugs
Ultragenyx and Kyowa Kirin say they will submit a supplemental BLA to FDA for their Crysvita (burosumab) for treating FGF23-related hypophosphatemia associated with phosphaturic mesenchymal tumors that can’t be curatively resected or localized. The companies say the decision to submit the sBLA follows a meeting with FDA and
Drugs
A Reuters investigative report, based on confidential federal court documents that were exposed due to filing errors, says New York federal judge Brian Cogan, who is hearing multi-district litigation against Merck’s Propecia, allowed the company to keep medical secrets contained in documents marked confidential by the company out
Drugs
Hospira has recalled one lot (# W20308) of its bacteriostatic water for injection, USP, 30 mL, multi-dose vial due to sterilization concerns. “In the event that impacted product is administered to a patient, there is an increased risk that severe adverse events such as invasive bacterial infection, including bacterial meningitis,
Drugs
After a 9/11 White House meeting between FDA acting commissioner Ned Sharpless, HHS secretary Alex Azar and President Donald Trump, the agency is moving forward to ban non-tobacco-flavored e-cigarettes, including mint and menthol. FDA is preparing an enforcement and compliance guidance in the coming weeks to
Drugs
FDA has accepted for review a Puma Biotechnology supplemental NDA for Nerlynx (neratinib) in combination with capecitabine for treating patients with HER2-positive metastatic breast cancer who have failed two or more prior lines of HER2-directed therapy. FDA has set a late 4/2020 user fee review action date,
Devices
FDA has granted Checkpoint Surgical a breakthrough device designation for the company’s brief electrostimulation therapy (BEST) system. The device is designed to provide electrical stimulation of peripheral nerves to promote nerve regeneration as an adjunct to surgical intervention following nerve injury. The company says it is enrolling patients in
Drugs
CDER director Janet Woodcock told 150 researchers at the Breakthroughs in Medicine conference 9/6 that there is a need for major reforms in scientists’ relationships with regulators, doctors, and one another. And without a wide-ranging overhaul, she cautioned, lab successes won’t make it to the patients who
Drugs
A 3/19-3/21 FDA inspection at Hangzhou Badi Daily Use Chemical Company, Zhejiang Province, China, found significant violations of current good manufacturing practice (CGMP) regulations. An 8/29 Warning Letter says specific violations were: * failing to have, for each batch of drug product, appropriate laboratory determination of satisfactory
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Enprani Co., Seoul, South Korea (8/15): FDA inspected the firm in March and cited significant GMP violations for finished pharmaceuticals. For example, The company failed to have, for
Drugs
Public Citizen 9/10 has filed suit in Washington, DC federal court against FDA over its inaction to respond to the group’s 7/2018 citizen petition urging a ban on all dietary supplements containing cesium chloride or other cesium salts from the market. Because its year-old petition has
Biologics
FDA says agency scientists have developed a technique that enables them to determine whether immune system cells (dendritic cells) appear primed to trigger the production of antibodies against Factor VIII products used to treat hemophilia A. “The technique might enable scientists to use the presence of such primed dendritic cells
Drugs
FDA has released the FDA-483 issued following an 8/19-8/23 inspection at Ipca Laboratories, Silvasa, India. The four inspection observations were: * deviations from written test procedures and laboratory mechanisms are not recorded and justified; * failing to thoroughly review any unexplained discrepancy and the failure of a batch
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