Biologics
FDA says Edge Pharma, Colchester, VT, is marketing mixtures of allergenic extracts for patient-specific allergy treatment, including some intended for sublingual immunotherapy. A 1/22 Notice of Violation says the firm’s patient-specific extracts and custom mix allergy immunotherapy vials that are not patient-specific can only be
FDA Policy/General
Harvard University government professor David Carpenter and Yale School of Public Health assistant professor Gregg Gonsalves are urging President Joe Biden to choose former FDA principal deputy commissioner Joshua Sharfstein as the new FDA commissioner. Writing in a Stat News opinion piece, Carpenter and Gonsalves say they have interacted with
Devices
CDRH says it has published three final guidance documents implementing the voluntary Accreditation Scheme for Conformity Assessment (ASCA) pilot program. The Center’s 2020 ASCA annual report identifies the three documents as a program guidance, basic safety and essential performance standards-specific guidance, and biocompatibility standards-specific guidance. “The ASCA
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Sage Moon Apothecary, Seal Harbor, ME (1/14): FDA has reviewed the company’s Web sites and determined that its products “Golden Milk Electuary-Mushroom Cocoa Blend,” “Golden Milk
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) says its regulatory attention in 2021 will focus on promotional materials involving high-risk drugs like opioids. “We want to make sure the promotional materials accurately convey the risks associated with these drugs, convey responsible use of opioids, and do not inadvertently
FDA Policy/General
Federal Register notice: FDA has withdrawn a 1/21-posted final rule that provided additional information on the content and format of reports intended to demonstrate substantial equivalence of a tobacco product (SE Reports). The rule also established general procedures FDA intends to follow when evaluating SE Reports, including procedures
FDA Policy/General
Federal Register notice: FDA has withdrawn a 1/21-posted final rule that outlines requirements for premarket tobacco product applications (PMTAs) and requires manufacturers to maintain records establishing that their tobacco products are legally marketed. The withdrawal is in response to an ongoing review by the Biden Administration of regulatory
Devices
The Advanced Medical Technology (AdvaMed) Association has reiterated to FDA that early stakeholder engagement is critically important when the agency is considering medical device safety communications about currently marketed devices. In comments submitted to the agency regarding an 11/17/2020 public meeting on “Communications About the Safety of Medical
Drugs
Merck says it is discontinuing developing two Covid-19 vaccine candidates, V590 and V591 based on Phase 1 data showing that the immune responses were inferior to those seen following natural infection and those reported for other Covid-19 vaccines. The Pfizer and Moderna mRNA vaccines that are currently on
Devices
FDA has cleared a Theranica 510(k) for its Nerivio therapeutic device for an expanded indication for acute treatment of episodic or chronic migraine in patients aged 12 years and older. The company says that about 10% of all school age children and up to 28% of teens between the
Drugs
FDA has accepted for priority review an Albireo Pharma NDA for odevixibat for treating pruritus in patients with progressive familial intrahepatic cholestasis (PFIC). Odevixibat is described as a potent, once-daily, non-systemic ileal bile acid transport inhibitor being developed to treat patients with rare pediatric cholestatic liver diseases, including
Drugs
FDA has approved an Aurinia Pharmaceuticals NDA for Lupkynis (voclosporin) in combination with a background immunosuppressive therapy regimen to treat adult patients with active lupus nephritis (LN), which causes irreversible kidney damage and significantly increases the risk of kidney failure, cardiac events, and death. Approval is based on data from
FDA Policy/General
New Tobacco Products Applications Guide Withdrawn Federal Register notice: FDA has announced the withdrawal of a draft guidance entitled Applications for Premarket Review of New Tobacco Products. The document is being withdrawn because the topics discussed in it are addressed in the final rule entitled “Premarket Tobacco Product Applications and
Devices
FDA has approved a Boston Scientific PMA for its fourth-generation Vercise Genus Deep Brain Stimulation (DBS) System. The approval covers conditional use in a magnetic resonance imaging environment. The Bluetooth-enabled, rechargeable and non-rechargeable device includes an implantable pulse generator that powers the Cartesia Directional Leads to provide
FDA Policy/General
HHS’s unprecedented overreach during the Trump Administration has drawn increased interest in making FDA an independent agency. “The durability and long-term effects of the department’s changes to FDA policy and its actions to limit the agency’s autonomy remain in question, but the public conversation about independence,
Drugs
FDA has approved an Exelixis NDA for Cabometyx (cabozantinib) in combination with Bristol Myers-Squibb’s Opdivo (nivolumab) for treating patients with advanced renal cell carcinoma (RCC), which is the most common form of kidney cancer. “This combination of cabozantinib and nivolumab significantly improved key efficacy measures compared to sunitinib
Drugs
FDA has given the green light to Ultragenyx Pharmaceutical to begin a seamless single-protocol Phase 1/2/3 study of UX701, an investigational AAV9 gene therapy being evaluated for treating Wilson Disease. “"The seamless Phase 1/2/3 clinical trial design will allow us to efficiently evaluate safety
Drugs
NJ attorney general Gurbir S. Grewal has announced a $5 million settlement with Insys Therapeutics founder John N. Kapoor to resolve allegations that he unlawfully bribed New Jersey doctors as part of a nationwide kickback scheme to boost sales of the company’s opioid drug Subsys. This is the first
Devices
The Medical Device Innovation Consortium (MDIC), which includes FDA as a member, will receive public comments until 2/22 on its External Evidence Methods Framework. An MDIC statement says the document is intended to help stakeholders navigate their way through the nuts and bolts of leveraging external data. Specifically, the
Biologics
FDA has published an immediately effective guidance, Manufacturing Considerations for Licensed and Investigational Cellular and Gene Therapy Products During Covid-19 Public Health Emergency, to give manufacturers of such products risk-based recommendations to minimize potential transmission of the SARS-CoV-2 novel coronavirus. The document is intended to supplement
Drugs
FDA has accepted for priority review a Genentech supplemental NDA for Esbriet (pirfenidone) for treating unclassifiable interstitial lung disease. The agency is expected to make a review decision in May. Esbriet was originally approved in 2014 for treating idiopathic pulmonary fibrosis. The submission is based on data from a pivotal,
FDA Policy/General
Federal Register notice: FDA has announced the withdrawal of a draft guidance entitled Applications for Premarket Review of New Tobacco Products. The document is being withdrawn because the topics discussed in it are addressed in the final rule entitled “Premarket Tobacco Product Applications and Recordkeeping Requirements.” To view the notice,