Drugs
Bausch Health Companies has received only the second untitled letter from CDER’s Office of Prescription Drug Promotion (OPDP) this year, citing the firm over its promotional communications, a direct-to-consumer video, and an efficacy Web page on its healthcare professional Web site for Duobrii (halobetasol propionate and tazarotene)
Devices
Sens. Chuck Grassley (R-IA) and Elizabeth Warren (D-MA) are ratcheting up pressure on FDA to issue its promised final rule allowing over-the-counter (OTC) hearing aids. The two lawmakers have just introduced their Delivering Over-the-Counter Hearing Aids Now Act to push the agency to finalize
Drugs
CMS has issued its long-awaited National Coverage Determination (NCD) on Medicare coverage of only FDA traditionally approved monoclonal antibodies that target amyloid (or plaque) for treating Alzheimer’s disease, which is a significant blow to Biogen’s controversial accelerated approval of Aduhelm (aducanumab). Additionally, CMS says that as part
Biologics
FDA has authorized a shelf life extension for Janssen’s refrigerated Covid-19 vaccine, allowing the product to be stored at 2-8 degrees Celsius for 11 months. The vaccine was previously authorized to be stored for up to nine months. This extension applies to all refrigerated vials that have
Drugs
The Department of Justice says that Raidel Figueroa, the former CEO and co-founder of Pharmatech, a drug and dietary supplement manufacturer that operated in Broward County, FL, has been charged with conspiring to manufacture and distribute drugs outside FDA regulatory oversight and to interfere with and obstruct FDA. A
Devices
FDA has published a draft guidance, Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions, that replaces a 2018 draft guidance on content of premarket submissions for management of cybersecurity in medical devices. FDA says the new version is intended to “further emphasize the importance of ensuring
Drugs
Federal Register notice: FDA is making available a draft ICH guidance entitled “M7(R2)Addendum: Application of the Principles of the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes.” The document adds monographs for seven new compounds to the M7 Guideline which outlines considerations for assessment and control
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment” that provides general recommendations on the clinical development of such products. It includes general considerations for nonclinical toxicology and virology studies, early phase clinical development, clinical pharmacology assessments, and Phase
Drugs
Bayer is petitioning FDA to confirm that it will stay final approval of an Apotex ANDA citing Bayer’s Astelin (azelastine HCl) nasal spray as the reference-listed drug until the expiration of the 30-month period beginning on the date Bayer received the Apotex Paragraph IV certification. The Bayer
Drugs
Minerva Neurosciences says the minutes of its 3/2 Type C meeting with FDA on the development of roluperidone to treat negative symptoms of schizophrenia show the agency continues to have significant concerns about a proposed NDA while acknowledging an unmet need for negative symptom treatments and urging Minerva to
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Medical Devices; Humanitarian Use Devices — 21 CFR Part 814” (OMB Control Number 0910-0332). The revision addresses a Food Drug & Cosmetic Act provision mandating that the HHS secretary determine the annual distribution number (ADN) for devices
Devices
FDA has published a draft guidance, Use of Whole Slide Imaging in Nonclinical Toxicology Studies: Questions and Answers, to provide information to sponsors and nonclinical laboratories about using and managing whole slide images used during histopathology assessment and/or pathology peer review performed for good laboratory practice (GLP)-compliant nonclinical
FDA Policy/General
FDA commissioner Robert Califf has laid out a six-part action plan to better leverage health technology, data, and capabilities to improve healthcare outcomes and equity. GovCIO Media reports Califf said during the 4/4 Health Datapalooza that there is a need for private and public entities to work together
Drugs
FDA’s reliance on its mutual recognition agreement (MRA) with the EU significantly helped the agency assess drug manufacturing quality during the pandemic and it is expected to be used even more after the public health emergency is over, according to FDA associate commissioner for regulatory affairs Judith McMeekin. Speaking
Biologics
CBER director Peter Marks says there are steps FDA and other stakeholders could take that would expedite the development of gene therapies. Writing in Expert Opinion on Biological Therapy, Marks says one place to start would be to consider whether the current framework for the development of small molecule drugs
Drugs
FDA has published a guidance, Chronic Hepatitis B Virus Infection: Developing Drugs for Treatment, to assist sponsors in the clinical development of drugs and biologics to treat chronic hepatitis B infection from the initial IND through the NDA or BLA and postmarketing phases. The document does not address the development
Drugs
FDA has published for comment a draft of the International Council for Harmonization (ICH) Addendum to M7(R2) containing revisions to the ICH M7 Guideline to Calculation of Compound-Specific Acceptable Intakes. The document contains the list of revisions to the M7 guideline and the new monographs for the seven
Drugs
GlaxoSmithKline says an FDA draft guidance on immunogenicity information in human prescription therapeutic protein and select drug product labeling content and format does not address where to place the information for labels subject to regulation at 21 CFR 201.80 rather than the 21 CFR 201.56 and 201.57
FDA Policy/General
Federal Register notice: FDA is announcing a 4/19 virtual public meeting entitled “Medical Device User Fee Amendments” to discuss proposed recommendations for the Medical Device User Fee Amendments reauthorization for fiscal years 2023 through 2027. The meeting is intended to give the public an opportunity to present its views
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision entitled “Current Good Manufacturing Practices for Positron Emission Tomography Drugs — 21 CFR Part 212” (OMB Control Number 0910-0667). To view the notice, click here.
Drugs
FDA has published the October-December 2021 listing of potential signals of serious risk/new safety information identified by the FDA Adverse Event Reporting System. For each of the listings, FDA says it is evaluating the need for regulatory action.
Devices
Medtronic says long-term data from the first 80 patients in the SPYRAL HTN-ON MED trial showed that patients who were prescribed anti-hypertensive medications and treated with the Medtronic Symplicity Spyral Renal Denervation System continued to show durable, clinically significant blood pressure reductions through three years. The company