FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Use of Circulating Tumor DNA for Early-Stage Solid Tumor Drug Development.” The document is intended to help sponsors planning to use circulating cell-free plasma derived tumor deoxyribonucleic acid as a biomarker in cancer clinical trials conducted under
Drugs
Harvard University researchers say the percentage of drugs referred for advisory committee review has dropped from 59% in 2011 to 6% in 2021. Writing in Health Affairs, the researchers say meaningful reforms of the advisory committee process could better ensure public trust in an agency decision to allow a drug
Drugs
Pfizer’s Covid-19 treatment Paxlovid (nirmatrelvir tablets and ritonavir tablets) is now widely available in community pharmacies and is authorized for treating mild-to-moderate Covid-19 in adults and pediatric patients age 12 and older with positive results of direct SARS-CoV-2 viral testing who are also
Devices
FDA is permitting marketing of Fujirebio Diagnostics’ Lumipulse G β-Amyloid Ratio (1-42/1-40) test, the first in vitro diagnostic test for early detection of amyloid plaque associated with Alzheimer’s disease. An agency announcement says the test is intended to be used in adult patients, age 55
FDA Policy/General
Attorney Dara Levy (Hyman, Phelps & McNamara) says additional FDA enforcement over the increasing sponsor use of so-called native advertising is likely. (Native advertising can be defined as the use of paid ads that match the look, feel, and function of the media format in which they appear.) Writing
Drugs
The International Council on Harmonization says its Model-Informed Drug Development (MIDD) Discussion Group, which was established in 1/2021, has posted a roadmap with respect to future MIDD-related guidelines. Access the roadmap here.
FDA Policy/General
The House Energy and Commerce Committee has released a “comprehensive legislative package” to reauthorize FDA user fee agreements and enhance other agency program areas. The legislation, “Food and Drug Amendments of 2022,” will be introduced this week, followed by a Health Subcommittee mark up next week. According to a summary
Devices
FDA has released a revised final guidance entitled Supplements for Approved Premarket Approval (PMA) or Humanitarian Device Exemption (HDE) Submissions During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. The document outlines the agency’s policy to help address current manufacturing limitations or supply chain issues due to disruptions
Drugs
Sens. Maggie Hassan (D-NH) and Mike Braun (R-IN) are calling on FDA commissioner Robert Califf to “update FDA’s opioid labeling practices to reflect current public health and safety knowledge.” In a 4/28 letter, the two cite 2021 opioid death statistics from their states and assert that
Drugs
FDA has lifted a clinical hold on Pfizer’s giroctocogene fitelparvovec (Hemophilia A gene therapy), the company disclosed in a 5/3 earnings announcement. The hold was placed on the Phase 3 AFFINE study 11/3/2021 following observance of Factor VIII levels greater than 150% in some study participants.
Devices
FDA is proposing that a Section 518(b) order be issued to require Philips Respironics to submit a plan for the repair, replacement, or refund of the purchase price of recalled devices manufactured after 11/2015. In 6/2021, FDA says, Philips recalled certain ventilators, bi-level positive airway pressure,
Drugs
Writing in a New England Journal of Medicine Perspective piece, CDER executives John Concato and Jacqueline Corrigan-Curay say that more than five years after the passage of the 21st Century Cures Act, the terms real-world data (RWD) and real-world evidence (RWE) continue to be used inconsistently and
Devices
FDA has granted Limaca Medical a breakthrough device designation for its Precision-GI endoscopic ultrasound biopsy product. The device is designed to obtain tumor tissue within or adjacent to the gastrointestinal tract using the ultrasound visualization endoscope, according to the company. “Precision-GI is deployed and operated through an instrument
Devices
FDA has published three guidances relating to implementing a standard adopted by the International Council for Harmonization (ICH) for electronic transmission of individual case safety reports (ICSRs). The first guidance, E2B(R3) Electronic Transmission of Individual Case Safety Reports (ICSRs) Implementation Guide—Data Elements and Message Specification, focuses on technical
Devices
Vision Advocacy president Paula Cofer, who also moderates a Facebook support group of over 7,000 people who suffer from complications associated with refractive eye surgery, such as LASIK, PRK, SMILE, and phakic intraocular lenses, has asked FDA commissioner Robert Califf to take regulatory action against refractive eye surgery providers
Biologics
As FDA begins to move into the next phase of the Covid-19 public health emergency, it is positioning the agency and public to accept that Covid infections will be with us for the foreseeable future and will likely become an annual concern like seasonal influenza. Writing in a 5/
FDA Policy/General
Federal Register notice: FDA has announced a 6/17 Psychopharmacologic Drugs Advisory Committee meeting. Panel members are scheduled to discuss and vote on an Acadia Pharmaceuticals resubmitted supplemental NDA for a new indication for its Nuplazid (pimavanserin) — treating hallucinations and delusions associated with Alzheimer’s disease psychosis. FDA issued a
Drugs
An 11/1-11/5/21 FDA inspection at a contract testing laboratory operated by the Miami University Department of Chemistry and Biochemistry, Oxford, OH, found significant deviations from current good manufacturing practice (CGMP) for active pharmaceutical ingredients (APIs). A 4/20 Warning Letter says specific deviations were: * failing to
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Administrative Detention and Banned Medical Devices” (OMB Control Number 0910-0114). The collection is related to FDA’s statutory authority to detain during inspections devices that are believed to be adulterated or misbranded. Agency regulations outline reporting
Drugs
FDA has issued HutchMed a complete response letter on its NDA for surufatinib, indicated for treating pancreatic (pNETs) and extra-pancreatic (epNETs) neuroendocrine tumors. The agency letter said that a multi-regional clinical trial (MRCT) is required for U.S. approval, according to the company. “FDA determined that the current
Drugs
FDA has denied an 11/2021 Public Citizen petition calling for the disqualification of two researchers at Hennepin County Medical Center, Minneapolis, MN, who “repeatedly and deliberately violated agency regulations intended to protect human subjects.” The advocacy group said the doctors conducted a series of clinical trials that tested the
FDA Policy/General
Federal Register notice: FDA has issued Regeneron Pharmaceuticals a priority review voucher under its material threat medical countermeasure product program. The voucher was awarded after FDA determined that Inmazeb (atoltivimab, maftivimab, and odesivimab-ebgn), indicated for treating infections caused by Zaire ebolavirus, met the program’s criteria. To view the