Drugs
GlaxoSmithKline Consumer Healthcare says that a 12/9/20 FDA draft guidance, Best Practices in Developing Proprietary Names for Human Non-prescription Drug Products, does not reflect best practice as it pertains to over-the-counter (OTC) drugs and that implementation of the guidance as written “could significantly limit our
Biologics
The CBER Office of Compliance and Biologics Quality says that Pacific Stem Cells, Newport Beach, CA, is marketing “stem cell therapy” products for stroke, macular degeneration, Lyme disease, Parkinson’s disease, heart disease, lupus, rheumatoid arthritis, and multiple sclerosis. A 2/17 Notice of Violation says Pacific appears to administer
Biologics
A new study has found that racial/ethnic minority groups and older adults are underrepresented in U.S.-based vaccine clinical trials. “These findings suggest that diversity enrollment targets should be included for all vaccine trials targeting epidemiologically important infections,” according to the study, which was published in the 2/
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Current Good Manufacturing Practices and Related Regulations for Blood and Blood Components; and Requirements for Donation Testing, Donor Notification, and ‘Lookback’” (OMB Control Number 0910-0116). The collection supports regulations that require manufacturers of biological products, which
FDA Policy/General
Federal Register notice: FDA is seeking public comments on an information collection extension associated with its “Guidance for Industry and FDA Staff — Class 2 Special Controls Guidance Document: Automated Blood Cell Separator Device Operating by Centrifugal or Filtration Separation Principle” (OMB Control Number 0910–0594)— Extension. The collection is authorized
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension entitled “Dispute Resolution Procedures for Science-Based Decisions on Products by the Center for Veterinary Medicine — 21 CFR 10.75” (OMB Control Number 0910–0566). The collection supports a guidance document under the same title, which describes the
Drugs
AstraZeneca has withdrawn an Imfinzi (durvalumab) indication, treating previously treated adult patients with locally advanced or metastatic bladder cancer, after confirmatory data did not support the indication, which was granted accelerated approval 5/2017. The withdrawal does not impact the indication outside the U.S., and does not affect other
Drugs
FDA has issued a new guidance and revised another to assist vaccine, diagnostic and therapeutic product developers to address the emergence and potential future emergence of Covid-19 variants. The new guidance is entitled Development of Monoclonal Antibody Products Targeting SARS-CoV-2, Including Addressing the Impact of Emerging Variants,
Biologics
BrainStorm Cell Therapeutics says FDA told it that the “current level of clinical data does not provide the threshold of substantial evidence” that the agency is seeking to support a BLA for NurOwn (autologous MSC-NTF cells) for treating amyotrophic lateral sclerosis (ALS or Lou Gehrig’s disease). The FDA
Drugs
FDA has issued a updated guidance for currently authorized Covid-19 vaccines that could be modified with limited data to address emerging variants. In announcing the guidance, FDA acting commissioner Janet Woodcock said the document will allow FDA and developers to pivot as the virus adapts. “At this time, available
Devices
FDA has cleared a Piccolo Medical 510(k) for its SmartPICC System that is intended to give healthcare providers the ability to navigate peripherally inserted central catheters (PICCs) to the entryway of the heart without relying on x-ray or fluoroscopy confirmation of correct catheter placement. The company says that
FDA Policy/General
Stakeholder Participation in Device User Fee Talks Federal Register notice: FDA is requesting notification from public stakeholders of their intent to participate in periodic consultation meetings on reauthorizing the Medical Device User Fee Amendments (MDUFA). Agency regulations require it to hold discussions (at least every month) with patient and consumer
FDA Policy/General
Federal Register notice: FDA is requesting notification from public stakeholders of their intent to participate in periodic consultation meetings on reauthorizing the Medical Device User Fee Amendments (MDUFA). Agency regulations require it to hold discussions (at least every month) with patient and consumer advocacy groups during FDA’s negotiations with
FDA Policy/General
Federal Register notice: FDA is announcing the availability of recent guidance documents related to the Covid–19 pandemic. The guidances have been implemented without prior comment, but they remain open for comment under the agency’s good guidance practices. They are available on FDA’s Web pages entitled COVID–19-
FDA Policy/General
Federal Register notice: FDA is updating its records to reflect five recent Emergency Use Authorizations (EUAs) for drug and biological products for use during the Covid–19 pandemic. FDA issued EUAs to: Baxter for Regiocit; HHS for Covid–19 convalescent plasma; , Eli Lilly for bamlanivimab; Regeneron Pharmaceuticals for casirivimab and
Drugs
Pfizer and BioNTech have submitted new stability data to FDA to permit their Covid-19 vaccine vials to be stored at warmer temperatures than their original authorization allowed for a total of two weeks as an alternative or complement to storage in an ultra-low temperature freezer. The data demonstrate
Devices
FDA has issued a safety alert on the limitations of pulse oximeters. “While pulse oximeters may be useful for estimating blood oxygen levels, these devices have limitations that can result in inaccurate readings,” the agency says. It adds: “Patients with conditions such as Covid-19 should not rely solely on
Devices
FDA has cleared an FX Shoulder 510(k) for the Easytech Stemless Anatomic, a shoulder prosthesis featuring primary peripheral fixation. The device’s design and Easytech Anchor base allows it to fit peripherally just inside the cortical bone where bone quality is optimal for fixation, the company says. It is
Drugs
An FDA study of refuse-to-file (RTF) letters found that 4% of CDER submissions from 2008 to 2017 were issued an RTF. “Overall, 84.5% (544 of 644) of the refusal reasons were for scientific deficiencies; most reasons were related to drug efficacy and safety (196 [30.4%]) and
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Certification To Accompany Drug, Biological Product, and Device Applications or Submissions (Form FDA 3674)” (OMB Control Number 0910–0616). To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is publishing a list of information collections that have been approved by the Office of Management and Budget. They are: * Infant Formula Recall Regulations * State Petitions for Exemption from Preemption * Product Jurisdiction and Combination Products * Exceptions or Alternatives to Labeling Requirements for Products Held by the
FDA Policy/General
Although the CDER Office of Prescription Drug Promotion (OPDP) issued fewer enforcement letters in 2020 than in 2019, two Arnall Golden Gregory attorneys say they see little change in enforcement policy or practices in 2021. Their analysis finds that OPDP “will continue to focus its enforcement energies going after false