FDA Policy/General
Retired FDA psychiatry products director Thomas Laughren has joined BetterLife Pharma as a regulatory advisor. BetterLife describes itself as an emerging biotechnology company developing second generation psychedelics for neuro-psychiatric disorders. It is also refining and developing drug candidates from a broad set of complementary interferon-based technologies which have
FDA Policy/General
FDA and the Federal Trade Commission say their review of Web sites and social media sites maintained by Allure Imports, Sault Sainte Marie, MI, established that the company markets products that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19 in humans or animals. A 4/7 Warning
FDA Policy/General
It’s been two and a half months since the inauguration and the Biden Administration does not appear to be in any rush to nominate an FDA commissioner, which could leave current acting commissioner Janet Woodcock at the helm for almost the remainder of the year, if the administration so
Drugs
Two Troutman Pepper attorneys cite four FDA March Warning Letters to companies selling CBD products as evidence that the agency is taking a strong stance on product labeling and marketing efforts involving health claims about CBD. Their online post also says that two of the four letters cited companies for
FDA Policy/General
Former FDA lawyer Sonia Wadhwa Nath has joined Cooley as a partner in the law firm’s business litigation and healthcare regulatory practice groups based in Washington, DC. A near 12-year agency veteran, she previously served as senior counsel in the Office of the Chief Counsel, handling enforcement cases
FDA Policy/General
FDA has issued a Warning Letter to Natural Adventure (Miramar, FL) after reviewing its Web site (www.mynaturaladventure.com) and social media sites and determining its hand sanitizers are unapproved new drugs. In the letter, FDA objected to numerous claims the company made regarding its products. For example, one claim
FDA Policy/General
Federal Register notice: FDA has announced a 5/11-12 Science Advisory Board to the National Center for Toxicological Research (NCTR) advisory committee meeting. On 5/11, the NCTR director will provide a Center-wide update on scientific initiatives and accomplishments during the past year. Each agency product center will
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension entitled “Medical Device Recall Authority — 21 CFR part 810” (OMB Control Number 0910-0432). FDA regulations provide it with the authority to issue an order requiring an appropriate person, including manufacturers, importers, distributors, and retailers of a device,
FDA Policy/General
Guidance on Combination Product Feedback Federal Register notice: FDA makes available a final guidance entitled Requesting FDA Feedback on Combination Products.To view the notice, click here. 4/02/2021 Protective Barrier Enclosures, Infusion Pump EUAs Revoked Federal Register notice: FDA is announcing the revocations of Emergency Use Authorizations (EUAs)
FDA Policy/General
Federal Register notice: FDA has announced an Emergency Use Authorization (EUA) revocation of NovaSterilis’ Nova2200 using the NovaClean decontamination process. The EUA covered the decontamination of compatible N95 respirators. In revoking the device’s use, FDA says it reviewed new data indicating that certain respirators may not maintain adequate fit
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Ardelyx’s Ibsrela (tenapanor hydrochloride), indicated for treating irritable bowel syndrome with constipation in adults. The review period was determined to be 3,219 days, which includes 2,853 days that occurred during the testing
FDA Policy/General
Federal Register notice: FDA is amending the animal drug regulations to reflect application-related actions for new animal drug applications and abbreviated new animal drug applications during October, November, and December 2020. The agency is also informing the public about the availability of summaries of the basis of approval and
FDA Policy/General
FDA acting commissioner Janet Woodcock has identified five key activities the agency experienced during the Covid-19 pandemic that will be expanded or continued after the public health emergency has ended. “As we continue our Covid-19 response, it is critical that we learn from both our successes and the
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Siga Technologies’ Tpoxx (tecovirimat monohydrate), indicated for treating human smallpox disease in adults and pediatric patients weighing at least 13kg. The review period was determined to be 4,601 days, which includes 4,383 days
FDA Policy/General
Federal Register notice: FDA has determined that Fougera Pharmaceuticals’ Cutivate (fluticasone propionate) ointment, 0.005%, was not withdrawn from sale for safety or effectiveness reasons. The determination will allow FDA to continue to approve ANDAs that refer to the product as long as they meet relevant legal and regulatory requirements.
FDA Policy/General
Federal Register notice: FDA has determined that Novartis’ Serentil (mesoridazine besylate) tablets 10 mg, 25 mg, 50 mg, and 100 mg were not withdrawn from sale for safety or effectiveness reasons. Serentil is indicated for managing schizophrenic patients who fail to respond adequately to treatment with other antipsychotic drugs. The
FDA Policy/General
Federal Register notice: FDA is correcting an 8/31/2016 amended final rule that listed inaccurate cross-references to FDA’s drug establishment registration and drug listing regulations. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes the regulatory review period for Veryan Medical’s Biomimics 3D Vascular Stent System, indicated to improve luminal diameter in treating symptomatic de novo or restenotic lesions in the native superficial femoral artery and proximal popliteal arteries, with reference vessel diameters
FDA Policy/General
Federal Register notice: FDA is amending its medical device regulations to make an editorial nonsubstantive change and replace a reference to an obsolete office with updated information. The regulations specified in the notice have been revised to correct “director of the Office of Regulatory Program” to “director or Principal Deputy
FDA Policy/General
Federal Register notice: FDA has announced a 5/27 Endocrinologic and Metabolic Drugs Advisory Committee meeting. Panel members are scheduled to discuss the safety and efficacy of a Provention Bio BLA for teplizumab intravenous infusion, indicated for the delay or prevention of clinical Type 1 diabetes mellitus in at-risk
FDA Policy/General
Federal Register notice: FDA has announced a 5/26-27 workshop entitled “FDA Science Forum 2021.” The workshop will discuss FDA research, including: (1) improving clinical and postmarket evaluation; (2) substance use, misuse, and addiction; (3) product development and manufacturing; and (4) medical countermeasures, infectious disease, and pathogen-reduction technologies.
FDA Policy/General
Federal Register notice: FDA is amending its electronic import entries regulation to correct the statutory citation in the sections of that regulation requiring submission of the Drug Registration Number for human drugs and for animal drugs. The revisions are necessary to correct editorial errors and to ensure that the codified