Drugs
A lengthy Bloomberg Businessweek report looks at the ongoing issue of N- nitrosodimethylamine (NDMA) contamination in the widely-used hypertension medicine valsartan. The contamination led FDA in 7/2018 to oversee a recall of drugs from three companies. There have been 51 additional recalls since then, including two additional drugs,
Drugs
An opinion column posted online by CNN says that a key source of the problem of high drug costs is abuse of the U.S. patent system. “Healthcare costs could be brought down through greater availability of generic drugs and biosimilars — drugs that are identical to branded drugs but distributed
Drugs
The FDA Allergenic Products Advisory Committee meets 9/13 to consider Aimmune Therapeutics’ BLA for Palforzia (peanut allergen powder) with a proposed indication to reduce the incidence and severity of allergic reactions, including anaphylaxis after accidental exposure to peanut in patients aged 4 through 17 years with a confirmed diagnosis
Drugs
Bayer says an FDA draft guidance on the content and format of instructions for use (IFU) for drug, biologic, and combination products “provides an opportunity to align with the previous effort by FDA to consolidate the current formats of patient labeling into patient medication information (PMI). The finalization of this
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,
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
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
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,
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
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
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
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