Drugs
As FDA begins to transition out of the Covid-19 pandemic, CDER Office of Prescription Drug Promotion (OPDP) staff are likely to resume attending in-person medical conferences and trade shows and will presumably have a renewed interest in reviewing materials disseminated and assessing interactions at the booths in these
FDA Policy/General
FDA Amends Animal Drug Regs for Approvals 2/25/2022 Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for NADAs, ANADAs and conditionally approved NADAs made during 7/2021, 8/2021 and 9/2021. Additionally, the agency is informing the public about the
FDA Policy/General
Avara Pharmaceutical Services has signed an agreement with Pfizer to acquire its Liscate, Italy sterile manufacturing facility. Avara Pharmaceutical Services is a contract manufacturing and technical services company providing both active pharmaceutical ingredient formulation and manufacturing, along with secondary formulation, manufacturing and packaging of small molecule drugs, including highly potent
FDA Policy/General
DEVICES FDA has cleared a bioMérieux 510(k) for the VIDAS 3 immunoassay analyzer. This newest version of the device features enhanced automation, improved traceability and new software capabilities, as well as a quality control program in compliance with laboratory certification standards, the company says. Corvida Medical has received FDA
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for NADAs, ANADAs and conditionally approved NADAs made during 7/2021, 8/2021 and 9/2021. Additionally, the agency is informing the public about the availability of summaries of the basis of approval and of
FDA Policy/General
Federal Register notice: FDA is withdrawing approval of five ANDAs from multiple applicants after they notified the agency that the drug products are no longer marketed and requested their withdrawal. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Exemptions From Substantial Equivalence Requirements for Tobacco Products” (OMB Control Number 0910-0684). FDA’s regulations establish a pathway for manufacturers to request exemptions from substantial equivalence requirements for tobacco products that are modified by adding or
FDA Policy/General
Federal Register notice: FDA is announcing a 3/22 virtual public meeting entitled “Final Assessment of the Program for Enhanced Review Transparency and Communication in the Biosimilar User Fee Act (BsUFA),” and an opportunity for public comment. The topics to be discussed are the final assessment and public stakeholder views
FDA Policy/General
CDER Office of Prescription Drug Promotion senior social science analyst and research team lead Katherine Aikin says her group investigates how healthcare providers and patients perceive medical product information about prescription drugs and make subsequent treatment decisions. Interviewed for an online post, Aikin says her team usually has about 20
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Nonclinical Considerations for Mitigating Nonhuman Primate Supply Constraints Arising from the Covid-19 Pandemic.” The agency says that during the pandemic there has been a significant reduction in the supply of nonhuman primates available for conducting toxicology studies for
FDA Policy/General
Federal Register notice: FDA is publishing a proposed rule to amend medical device current GMP requirements of the Quality System Regulation to align more closely with the International Organization for Standardization’s 13485. It is also proposing additional requirements to clarify device GMP requirements for combination products. To view the
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a 9/22/21 video interview with the then-CEO of CytoDyn, Vancouver, WA, represented in a promotional context that leronlimab, an investigational new drug, is safe and effective for the purpose for which it is being investigated. Specifically, according to
FDA Policy/General
More Product-specific Guidances for ANDAs 2/18/2022 Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that provide recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here. Info Collection Extension on CDRH Appeals Processes
FDA Policy/General
Palatin Technologies has entered into a collaboration and license agreement with Shanghai Fosun Pharmaceutical Industrial Development Co. to develop and commercialize bremelanotide for female sexual dysfunction (FSD) indications. Bremelanotide is an investigational product designed for on-demand treatment of hypoactive sexual desire disorder (HSDD) in premenopausal women. Under the agreement,
FDA Policy/General
DEVICES FDA has approved a CeloNova Biosciences PMA for its COBRA PzF NanoCoated Coronary Stent System. The device, which is coated with a biocompatible proprietary nanothin polymer, requires a minimum 30-day dual antiplatelet therapy regimen after intervention, according to the company. The stent is designed to improve coronary luminal
FDA Policy/General
Federal Register notice: FDA has made available additional draft and revised draft product-specific guidances that provide recommendations on, among other things, bioequivalence study designs to support ANDAs. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Center for Devices and Radiological Health Appeals Processes” (OMB Control Number 0910-0738). The collection supports implementation of recommendations found in FDA’s 2019 Center for Devices and Radiological Health (CDRH) Appeals Processes guidance. To view the
FDA Policy/General
Federal Register notice: FDA is classifying the electromechanical tear stimulator into medical device Class 2 (special controls). The action is based on an Olympic Ophthalmics de novo classification request for its iTEAR100 Neurostimulator. The agency has identified it as being a non-implantable device intended to increase tear production via
FDA Policy/General
Federal Register notice: FDA is classifying the integrated continuous glucose monitoring system into medical device Class 2 (special controls). The action is based on a Dexcom de novo classification request for the Dexcom G6 Continuous Glucose Monitoring System. The agency has identified the device as being intended for use to
FDA Policy/General
Federal Register notice: FDA is classifying the percutaneous catheter for creation of an arteriovenous fistula for hemodialysis access into medical device Class 2 (special controls). The action follws a TVA Medical de novo classification request for its everlinQ endoAVF System. The agency has identified the device as being a single-
FDA Policy/General
The Alliance for a Stronger FDA says that commissioner Robert Califf’s first priorities should focus on “renewed attention” to data and technology modernization at the agency, and “vigorous support for FDA staff who have been working non-stop for two years without any break.” These were recommendations the Alliance
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Investigational New Drug Application Regulations — 21 CFR part 312” (OMB Control Number 0910-0014). The information collection reflects program changes and adjustments. The agency has revised it further to account for burdens that may be incurred by