Drugs
The CDER Office of Generic Drugs (OGD) approved or tentatively approved 956 generic drug applications in 2023. The OGD 2023 Annual Report says there were 90 first generic medicines approved. It notes that first generics “provide access where no generic competition previously existed [and] because of their importance to public
Drugs
Hogan Lovells attorneys Lowell Zeta and Blake Wilson say actions that FDA will and will not take this year will vary in part because this is a presidential election year. Zeta and Wilson were joined by Greenleaf Health executive vice president for regulatory compliance Kalah Auchicloss and executive vice president
Devices
FDA has granted Better Therapeutics a breakthrough device designation for its Cognitive Behavioral Therapy (CBT) platform that is intended to treat adults with metabolic dysfunction-associated steatohepatitis (MASH). The designation is based on data from the company’s LivVita clinical study, which met its primary endpoint by reducing liver fat
FDA Policy/General
Federal Register notice: FDA is making available a final guidance entitled “Assessing Covid–19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for COVID–19 Prevention or Treatment.” The document is intended to provide sponsors and investigators with considerations for approaches on
FDA Policy/General
Federal Register notice: FDA is issuing an order debarring Taylor McLaren for five years from importing or offering for import any drug into the U.S. The action is based on his conviction of one felony count for conspiracy to smuggle prescription drugs into the U.S. To view the
Drugs
FDA has granted a Universities Allied for Essential Medicines 2/27/23 petition request that the agency consider a different enforcement framework in its approach to registration of applicable clinical trials at ClinicalTrials.gov. “We believe that … the agency’s current enforcement policy … has been effective,” the FDA response says.
Devices
FDA has cleared a ClearPoint Neuro 510(k) for use of its ClearPoint 2.2 software with the integrated Maestro Brain Modeling. “The ClearPoint system can now offer fast, peri-procedural segmentation of the cortical structures of the brain to identify both targets and safety zones for cell and gene
Devices
FDA has cleared a Zimmer Biomet 510(k) for the ROSA Shoulder System for robotic-assisted shoulder replacement surgery. The device is intended to give surgeons the flexibility to complete a total shoulder replacement using anatomic or reverse techniques and to “enable precise placement for improved outcomes,” the company says.
Drugs
FDA has accepted for review a Daiichi Sankyo and AstraZeneca BLA for datopotamab deruxtecan (Dato-DXd) for treating adult patients with locally advanced or metastatic nonsquamous non-small cell lung cancer (NSCLC) who have received prior systemic therapy. The agency has set a user fee review action target date of
FDA Policy/General
Federal Register notice: FDA is making available a draft guidance entitled “Select Updates for the Medical Device User Fee Small Business Qualification and Certification Guidance.” The document describes how FDA plans to determine if a small business is experiencing “financial hardship” which makes them eligible for a waiver of their
Drugs
FDA has published an immediately effective new final guidance, Assessing Covid-19-Related Symptoms in Outpatient Adult and Adolescent Subjects in Clinical Trials of Drugs and Biological Products for Covid-19 Prevention or Treatment, to give sponsors and investigators considerations for approaches on how common Covid-19-related symptoms can
Devices
The Medical Device Manufacturers Association (MDMA) says it is concerned that some aspects of an FDA draft guidance on using real-world evidence (RWE) to support regulatory decision-making for medical devices “place overly restrictive burdens on the use of RWE and real-world data (RWD) are not consistent with
Devices
CDRH director Jeffrey Shuren says more companies should be joining FDA’s Total Product Lifestyle Advisory Program (TAP) which is intended to help reduce the risk in the development process for new medical devices. Speaking 2/20 at the AAMI/FDA neXus device standards conference, Shuren said feedback on the
Drugs
The three top Democrats on the House Energy and Commerce Committee are urging FDA commissioner Robert Califf to quickly issue a congressionally mandated guidance on clinical trial diversity action plans that was due on 12/29/2023. In their 2/20 letter, Reps. Frank Pallone (D-NJ), Anna Eshoo (D-
Devices
FDA has posted a Medtronic customer letter with updated information for use, new training material, and unique device identifier information for its NIM CONTACT Reinforced EMG (electromyogram) Endotracheal Tube and NIM Standard Reinforced EMG Endotracheal Tube. The post says the updates include information on what to do when airway obstruction
Drugs
An FDA safety alert is warning healthcare professionals and consumers about the risks related to using smartwatches or smart rings that claim to measure blood glucose levels without piercing the skin. “These devices are different than smartwatch applications that display data from FDA-authorized blood glucose measuring devices that pierce
Biologics
FDA has approved a Johnson & Johnson supplemental BLA for Tecvayli (teclistamab-cqyv) for a reduced dosing frequency of 1.5 mg/kg every two weeks in patients with relapsed or refractory multiple myeloma (RRMM) who have achieved and maintained a complete response (CR). The therapy was originally approved 10/
Drugs
United Therapeutics says it is suing FDA over the agency’s decision to permit Liquidia Corp. to add a second proposed indication to its NDA for Yutrepia (treprostinil) inhalation powder. In a statement, United says FDA mistakenly permitted Liquidia to amend its NDA and “skirt longstanding FDA rules, precedents, and
FDA Policy/General
Federal Register notice: FDA is amending its standing advisory committee regulations to add the new Digital Health Advisory Committee. The committee was established 10/2023 to provide advice on complex scientific and technical issues related to digital health technologies (DHTs). This also may include advice on the regulation of DHTs
Devices
FDA is reminding sponsors of medical device studies and manufacturers of devices to carefully evaluate the third parties they engage to conduct performance testing and to independently evaluate all testing results before submitting them to the agency. A 2/20 online post says that in recent years FDA has observed
Drugs
CBER has issued a standard operating policy and procedure (SOPP), Postmarketing Requirement/Commitment Related Submissions — Administrative Handling, Review, and CBER Reporting, that applies to all postmarketing requirements (PMRs) and commitments (PMCs) for licensed biologics and drugs approved under an NDA regulated by CBER. The SOPP says that CBER will: * accurately
Drugs
Two policy executives with the Coalition for a Prosperous America say there are steps FDA, Congress, and other federal agencies could take to reduce drug shortages and the threat of medical device shortages. In a deeply-researched article in American Affairs, Nick Iacovella and Jon Toomey lay much of the