Drugs
FDA says that since the beginning of the Covid-19 pandemic it has been working to facilitate the development and availability of drugs for use by patients, doctors, and health systems as expeditiously as possible. In an online paper, CDER says several therapies are being tested in clinical trials to
Drugs
An FDA-issued safety alert warns health care professionals about the temporary absence of a “paralyzing agent” warning statement embossed on the vial caps of two neuromuscular blocking agents. Vecuronium bromide for injection 10 mg per vial and 20 mg per vial and rocuronium bromide injection 50 mg/5 mL,
Drugs
An 11/25-12/11/19 FDA inspection at LifeHealth Science, Twinsburg, OH, found multiple serious violations in the firm’s manufacturing and distribution of its ORËÁ dietary supplement. A 5/15 Warning Letter says that claims on the firm’s Web site establish that the product is considered to
Drugs
FDA commissioner Stephen Hahn says the agency has updated guidances to provide additional clarification on the manufacturing and compounding of certain alcohol-based hand sanitizer products to help ensure that harmful levels of impurities are not present in ethanol used in the hand sanitizer products. “FDA appreciates industry’s willingness
Drugs
Amneal Pharmaceuticals is recalling all lots of metformin HCl extended-release tablets, 500 mg and 750 mg after being informed by FDA that its testing of seven lots showed N-nitrosodimethylamine amounts above acceptable FDA levels. The agency recommended a recall of the seven tested lots, according to an online
Drugs
Public Citizen says that groups that oppose congressional principles to make future Covid-19 treatments and vaccines affordable and available for any manufacturer to produce have received millions of dollars in contributions from the drug industry in recent years. In a media statement, the advocacy group says that in early
Drugs
Government Accountability Office (GAO) healthcare director Mary Denigan Maculey says that the outbreak of Covid-19 has added “a level of complexity” to an already strained FDA system for inspecting drug manufacturers in foreign countries. Testifying before the Senate Finance Committee, Denigan-Maculey said that over the years since the
Drugs
FDA has posted a guidance entitled “Institutional Review Board (IRB) Review of Individual Patient Expanded Access Requests for Investigational Drugs and Biological Products During the COVID-19 Public Health Emergency Guidance for IRBs and Clinical Investigators.” The agency says the document is intended to address a “substantial increase in the
Drugs
An FDA internal review obtained by BuzzFeed News through a Freedom of Information Act request says the agency issued emergency use authorizations for two anti-malaria drugs (hydroxychloroquine and chloroquine) touted by President Donald Trump to treat Covid-19 “based on threadbare evidence.” An online post says the review “also
Drugs
As the U.S. becomes accustomed to living with the Covid-19 pandemic, FDA commissioner Stephen Hahn says it is time to look forward and evaluate the agency’s response to identify new opportunities. Addressing the Alliance for a Stronger FDA in a virtual update, Hahn said FDA needs to
Drugs
A Southern New York federal judge has ordered Sundial Herbal Products to stop distributing unapproved new drugs and misbranded drugs until it complies with federal law. According to the complaint, despite previous warnings from FDA and repeated promises to correct violations, Sundial continued to distribute its products. “The court concluded
Drugs
An FDA safety alert asks patients, caregivers and health care professionals to immediately inspect certain lots of Amneal and Impax epinephrine auto-injector 0.3 mg to ensure the yellow “stop collar” in the device is present. Letters to consumers and health professionals detail how certain lots of these devices
Drugs
CDER director Janet Woodcock says the fifth annual drug safety priorities report issued by the Center “describes the scope and scale of the Center’s drug safety oversight programs, detailing the evolving and wide-ranging nature of our safety operations, with updates on several of the year’s milestones and
Drugs
FDA has approved an Avid Radiopharmaceuticals NDA for Tauvid (flortaucipir F18) for intravenous injection, the first drug for helping image a distinctive characteristic of Alzheimer’s disease in the brain called tau pathology. The radioactive diagnostic agent is intended for adult patients with cognitive impairment who are being evaluated for
Drugs
FDA is providing a voluntary EUA template for device developers to use for Covid-19 at-home sample collection kits. The template reflects FDA’s current thinking on data and information that they should submit to facilitate the EUA process. In particular, it includes recommendations for use by laboratories and
Drugs
FDA says five drug firms will need to recall their metformin for diabetes drug products after sampling detected the impurity N-Nitrosodimethylamine (NDMA) above the agency’s acceptable intake limit (see earlier story). The agency contacted the firms and their recall notices will be posted accordingly on FDA’s Web
Drugs
FDA has issued a draft guidance, Orange Book Questions and Answers to help interested parties use the Orange Book. The document gives answers to commonly asked questions received from parties such as prospective drug product applicants, drug product applicants, and approved application holders. The Orange Book identifies drug products approved
Drugs
An FDA letter to healthcare facilities is reminding staff to use the correct decontamination cycle associated with certain models of the Advanced Sterilization Products Sterrad Sterilization Systems and to only decontaminate compatible N95 or N95-equivalent respirators for reuse during the Covid-19 pandemic. The letter says that the sterilization
Drugs
FDA says it has established a docket to obtain information and comments from patients, patient advocates, the scientific community, health professionals, other regulatory and health authorities in the global community, regulated industry, and the general public on steps and successful approaches to establishng a rare disease clinical trial network. A
Drugs
In a move to increase access to naloxone, perhaps even through regulatory approval of over-the-counter sales, CDER staff developed a model drug facts label for such sales to determine whether consumers understood the key statements for safe and effective use. Writing in a New England Journal of Medicine
Drugs
The Food and Drug Law Institute (FDLI) says over-the-counter drug monograph reforms included in the Coronavirus Aid, Relief, and Economic Security (CARES) Act give FDA additional resources and make the monograph system more nimble, transparent, certain, and conducive to innovation. In an online article, FDLI says the added
Drugs
FDA has issued an immediately-in-effect guidance, Effects of the Covid-19 Public Health Emergency on Formal Meetings and User Fee Applications—Questions and Answers, to give answers to frequently asked questions about regulatory and policy issues related to drug development for the duration of the HHS public health