Devices
The Medical Device Innovation Consortium (MDIC) has published its MDIC External Evidence Methods Framework, which was developed by experts from FDA, industry, and academia. MDIC says the framework is intended to help stakeholders navigate their way through the process of leveraging external data by harnessing the power of statistics. “The
Drugs
Simulations Plus, which says it provides modeling and simulation services for the pharmaceutical and biotechnology industries, says it has completed a project funded by FDA and the Center for Research on Complex Generics to establish the suitability of model-integrated evidence to demonstrate bioequivalence in long-acting injectable and implantable
Drugs
FDA is considering asking Congress for additional authority to have the option of requiring drug sponsors in their NDAs to demonstrate their product’s superiority over drugs that are already on the market. During a 4/28 Senate appropriations subcommittee hearing on FDA’s fiscal year 2023 budget request, commissioner
Drugs
The Biotechnology Innovation Organization (BIO) says it agrees with FDA that the rarity of pediatric cancers may render investigations of multiple same-in-class products unfeasible. The comment is included in the trade association’s response to the agency’s pediatric oncology subcommittee of the Oncologic Drugs Advisory Committee’s
Biologics
Moderna is asking FDA for an emergency use authorization for its mRNA-1273 Covid-19 vaccine in children 6 months to under 2 years and 2 years to 6 years old. A company statement says results from the Phase 2/3 KidCOVE study showed “a robust neutralizing antibody response in
Drugs
Lilly says its tirzepatide achieved superior weight loss compared to placebo in the 72-week Phase 3 SURMOUNT-1 study. A company statement says the drug met both co-primary endpoints of superior mean percent change in body weight from baseline and a greater percentage of participants achieving body weight
Drugs
FDA has lifted a clinical hold on Pfizer’s mini-dystrophin gene therapy, fordadistrogene movaparvovec, in ambulatory patients with Duchenne muscular dystrophy (DMD). The company is now planning to resume a Phase 3 study evaluating the therapy. The global study, CIFFREO, had been ongoing in 11 countries and was paused
Devices
Retired Ethicon senior principal quality engineer Eric Hinrichs says weighing risk versus reward is the key to successful medical device product development. And the way to make such an assessment, he writes in a Med Device Online guest column, is through using risk documents. “Failure mode and effect analysis documents
Drugs
Consulting firm McKinsey and Co. came under intense scrutiny 4/27 during a House hearing for its role in advising Purdue Pharm during the opioid epidemic while also being under contract to advise FDA. “We have learned that at the same time McKinsey was providing secret advice to Purdue to
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says the current methods used by the Federal Trade Commission (FTC) and Department of Justice (DoJ) to evaluate proposed drug company mergers are working well as demonstrated by FDA statistics. In its comment letter, PhRMA says the level of innovation output of drug
Drugs
FDA says Pfizer has recalled five lots of Accupril (quinapril HCl) due to the presence of N-nitroso-quinapril observed in recent testing above the acceptable daily limit level. An agency announcement says that to date the company is not aware of reports of adverse events that have been assessed
Drugs
FDA is interested in working with Congress to find a legislative solution, most likely a bill that would be added to the user fee reauthorization package that is moving through Congress, to help overturn a 2021 appeals court decision that has disrupted FDA’s orphan drug program. Asked to comment
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision entitled “Expanded Access to Investigational Drugs for Treatment Use” (OMB Control Number 0910-0814). The agency has proposed revisions to Form FDA-3926, Individual Patient Expanded Access Investigational New Drug Application. For example, it proposes to move from
Drugs
Janssen has filed suit in New York federal court to stop several drug wholesalers and their executives/founders from distributing counterfeit forms of Janssen’s Symtuza (darunavir/cobicistat/emtricitabine/tenofovir alafenamide), a multi-drug HIV medication in one tablet. The Janssen complaint names Safe Chain Solutions, Propharma Distribution, Scripts Wholesale,
Drugs
FDA has published a guidance, Providing Submissions in Electronic Format—Postmarketing Safety, providing general information on the electronic submission of specified postmarketing safety reports to CBER and CDER. The document does not apply to vaccines, whole blood or blood components, combination products with a drug or biological product constituent part
Devices
FDA says it is evaluating the potential risk of airway obstruction when using two Medtronic silicone-based electromyogram (EMG) endotracheal tubes. An agency letter to healthcare providers identifies the affected devices as the Medtronic NIM Standard Reinforced EMG Endotracheal Tube and the Medtronic NIM Contact Reinforced EMG Endotracheal Tube. The
FDA Policy/General
Federal Register notice: FDA is requesting that any industry organizations interested in participating in selecting a nonvoting industry representative to serve on the agency’s Pediatric Advisory Committee notify it in writing. To view the notice, click here.
Devices
CDRH Digital Health Center of Excellence director Bakul Patel tells the Association for the Advancement of Medical Instrumentation that in his new position as chief digital health officer of global strategy and innovation, he will focus on two key areas: developing a strategy for advancing digital health technology and addressing
Drugs
A 4/6-4/27/21 FDA inspection at the Clinical Resolution Laboratory drug manufacturing facility in Brea, CA, found significant violations of current good manufacturing practice (CGMP) regulations and other violations in its production of finished drugs. A just-released 3/1 Warning Letter says specific CGMP violations were:
Drugs
Attorney Bryan Feldhaus (DuVal & Associates) says his firm does not think the new FDA “intended use” rule published on 9/1/21 represents a material change for drug and device manufacturers in 2022. In this way, his analysis differs from some observers who have projected an increased exposure for
Drugs
A 9/13-9/22/21 FDA inspection at the Vitae Enim Vitae Scientific drug manufacturing facility in San Diego, CA, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 3/17 Warning Letter says specific violations were: * failing to establish and follow
Biologics
The House Select Subcommittee on the Coronavirus Crisis is asking FDA for a briefing on the status of coronavirus vaccine candidates for young children. A 4/25 letter says “millions of young children still remain unprotected because no vaccine has yet been authorized for children under five.” The select subcommittee