Devices
FDA is changing its Covid-19 test policy to reduce the number of tests reviewed for an emergency use authorization (EUA) and increase the number of tests authorized through the traditional de novo classification or 510(k) clearance pathways. In an online statement, FDA says more than 430 distinct Covid-
FDA Policy/General
Federal Register notice: FDA has modified the organizational structure of the Office of Regulatory Affairs and field offices. The new structure was approved by HHS 12/2021 and became effective 2/9. To view the notice, click here.
Devices
FDA has published a guidance, Clinical Decision Support Software, to clarify the scope of the agency’s oversight of clinical decision support (CDS) software intended for healthcare professionals. “Not all clinical decision support software used in healthcare settings are devices and therefore subject to FDA oversight as a device,” the
Drugs
A 2/28-3/4 FDA inspection at Zhejiang Tianyu Pharmaceutical Co., Zhejiang Sheng, China, found significant deviations from current good manufacturing practice (CGMP) regulations for active pharmaceutical ingredients (APIs). A just-released 8/17 Warning Letter says the specific deviations were: * failing to extend investigations to other batches that
FDA Policy/General
Federal Register notice: CBER’s Office of Tissues and Advanced Therapies has modified its organizational structures effective 9/16 to rename it the Office of Therapeutic Products (OTP) and elevate it to a super office to manage its program at a macro level and to better position the Center to
Drugs
Five researchers in CDER’s Office of Clinical Pharmacology say that “leveraging clinical pharmacology principles during drug development and evaluation can fulfill knowledge gaps and help the right patient receive the right drug, at the right dose, at the right time.” Writing in Clinical and Translational Science, the researchers say
Drugs
Rep. A. Donald McEachin (D-VA) has introduced the Updated Drug Labeling for Patient Safety Act to direct FDA to allow generic drug manufacturers to update their product labeling with safety-related information. A statement from McEachin says his bill would direct the agency to: * issue a final rule establishing
Drugs
FDA researchers from several disciplines say the use of pediatric extrapolation since 2015 “continues to be expanded and refined. As scientific evidence increases the knowledge and understanding for any given disease and therapeutic response, reevaluation of the optimized use of pediatric extrapolation should be considered during drug development.” Writing in
FDA Policy/General
In an expected move to avert sending pink slips to thousands of FDA employees next month, House and Senate negotiators have come to terms to reauthorize the agency’s user fee programs under a clean — absent any policy/program riders that the two chambers have earlier sought — measure that will
Drugs
FDA has issued a Warning Letter to German over-the-counter drug manufacturer System Kosmetik Produktionsgesellschaft fur kosmetische after inspecting the firm in February and citing GMP deviations. The letter says the firm failed to establish adequate written procedures for production and process controls, and provide data to demonstrate that
FDA Policy/General
Federal Register proposed rules: FDA is issuing two proposed rules that modify certain research requirements regarding approval/oversight by institutional review boards (IRBs). One proposed rule would replace current requirements for FDA-regulated cooperative research with new requirements that would require any institution located in the U.S. participating in
Drugs
Biogen has agreed to pay $900 million to resolve allegations that it violated the False Claims Act by causing the submission of false claims to Medicare and Medicaid by paying kickbacks to physicians to induce them to prescribe Biogen drugs. The whistleblower (qui tam) lawsuit was brought by former Biogen
FDA Policy/General
Pharmaceutical Research and Manufacturers of America (PhRMA) says it strongly supports the use of alternative tools for oversight of FDA-regulated products. Commenting on an agency draft guidance on questions and answers about conducting remote regulatory assessments (RRAs), PhRMA raises issues under two general headings in which it says FDA
Drugs
The Association of Health Care Journalists (AHCJ) is urging is journalist members to look deeper into FDA’s use of advisory committees in their regulatory decision making and the transparency about the agency’s decisions on when to seek expert feedback and instructions to its advisory committees. A 9/23
Drugs
Federal Register final rule: FDA is amending the color additive regulations to allow calcium carbonate’s use in dietary supplement tablets and capsules. This action is in response to a color additive petition submitted by Colorcon, Inc. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Ethical Considerations for Clinical Investigations of Medical Products Involving Children.” The document explains fundamental concepts for the ethical framework that IRBs, sponsors and industry should consider when reviewing or conducting clinical trials involving children, such as scientific necessity for
Devices
FDA says a recent pilot program on software as a medical device has shown that a new regulatory paradigm is needed to regulate such devices, but this would require a legislative change. Based on the observations from the pilot, FDA determined that the approach described in the pilot’s “working
Drugs
FDA has released three Form FDA-483s issued to India’s Biocon Biologics following three on-site August inspections at the company’s seven manufacturing sites in Bengaluru, India, and Johor, Malaysia. Biocon says the inspections were triggered by three preapproval inspections for biosimilar bevacizumab, rh-insulin, and insulin aspart,
Drugs
After three and a half years at the helm, CDER Office of Generic Drugs (OGD) director Sally Choe is leaving FDA effective 10/8 to “pursue opportunities outside the agency,” according to Center director Patrizia Cavazzoni. Choe rejoined FDA from a stint in industry in 2016 as CDER Office of
Drugs
Former New York cannabis programs director Norman Birenbaum has joined CDER’s Office of the Center Director as a senior public health advisor “responsible for advancing our efforts related to research and regulation of cannabis as a part of CDER’s work in controlled substances,” according to deputy Center director
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Exemption and Exclusion from Certain Requirements of the Drug Supply Chain Security Act for the Distribution of FDA-Approved Naloxone Products During the Opioid Public Health Emergency.” The document clarifies the scope of the law as it applies to
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Biohaven Pharmaceutical’s Nurtec ODT (rimegepant sulfate), indicated for the acute treatment of migraine with or without aura in adults. The regulatory review period period is 3,390 days, of which 3,144 days occurred