FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Policy for Testing of Alcohol (Ethanol) and Isopropyl Alcohol for Methanol, Including During the Public Health Emergency (Covid–19). The document is intended to alert pharmaceutical manufacturers and pharmacists in state- licensed pharmacies or federal facilities who engage in
FDA Policy/General
Federal Register notice: FDA is extending the comment period on a 1/11 notice requesting comments regarding a document entitled “Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper.” Electronic or written comments can now be submitted
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Adverse Experience Reporting for Licensed Biological Products and General Records — 21 CFR Part 600” (OMB Control Number 0910-0308). Agency regulation requires licensed manufacturers or any person whose name appears on the label of a licensed biological
FDA Policy/General
The CDER Office of Prescription Drug Promotion (OPDP) says a CooperSurgical direct-to-consumer video for Paragard (intrauterine copper contraceptive) is false and misleading by presenting efficacy claims for Paragard and failing to communicate any risk information associated with its use. A 2/12 Warning Letter says the video was
Drugs
FDA has denied a 2/26/18 Synergy Pharmaceuticals petition asking that the agency require specified revisions to the approved package insert for Forest Laboratories’ Linzess (linaclotide) capsules. The petition asked that FDA: * convert the Trial 5 safety data for the Linzess 72 mcg dose in patients treated for chronic
FDA Policy/General
Former FDA commissioner Stephen Hahn has joined clinical therapeutics Blackfynn’s board of directors. The firm says its approach to drug development is “grounded in its roots as a technology and data analysis company focused on neurodegenerative diseases. Blackfynn’s business model is to acquire and complete the development of
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Shortages Data Collections” (OMB Control Number 0910-0491). The agency’s regulations give CDRH authority to acquire and maintain detailed data on domestic inventory, manufacturing capabilities, distribution plans, and raw material constraints for medical devices that would
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. CooperSurgical, Trumbull, CT (2/12): CDER’s Office of Prescription Drug Promotion (OPDP) cited the firm’s direct-to-consumer video for Paragard (intrauterine copper contraceptive) as false and
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-