Biologics
FDA is continuing to closely monitor the various identified variants of the virus that causes Covid-19 and also monitoring for emerging variants, according to a series of 1/25 Tweets by FDA acting commissioner Janet Woodcock. Woodcock says the agency “will continue to factor in newly emerging information in
Drugs
Merck says an FDA draft guidance, Cross Labeling Oncology Drugs in Combination Regimens, is needed, given the increasing importance of oncology combination regimens for optimal patient treatment. “The guidance is informative, but does not include much information on acceptable trial design, except for a brief mention of FDA’s support
Drugs
FDA says its review of records and other information submitted by Yuyao Yijia Daily Chemical Co., Ningbo, China, a registered manufacturer of over-the-counter drug products, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 1/22 Warning Letter identifies specific violations as: * failing
Drugs
FDA has accepted for priority review a Vertex Pharmaceuticals supplemental NDA to expand the use of Trikafta (elexacaftor/tezacaftor/ivacaftor and ivacaftor) to include children ages six through 11 years old who have at least one F508del mutation in the cystic fibrosis transmembrane conductance regulator (CFTR) gene or a mutation
Drugs
Myovant Sciences and Pfizer say that data from the Phase 3 SPIRIT long-term extension study of an investigational once-daily relugolix combination therapy (relugolix 40 mg plus estradiol 1.0 mg and norethindrone acetate 0.5 mg) in women with endometriosis showed clinically meaningful reductions in dysmenorrhea (menstrual pain)
Drugs
CDER has issued its 2021 list of new and revised draft guidance documents planned for publication this year. The list covers 105 documents broken into 18 categories. The largest category is Procedural, with 22 guidances, followed by Generics, with 20 documents.
Devices
Faced with ongoing safety concerns about hand sanitizers coming from Mexico, FDA has decided to place all alcohol-based hand sanitizers from the country on import alert to intercept them until the agency is able to review their safety. “Over the course of the ongoing pandemic, the agency has seen
Devices
FDA has released the FDA-483 with eight inspection observations issued following a 3/2-4/6/20 inspection at CareFusion 303, a San Diego, CA, medical device manufacturer. The inspection observations were: * failing to adequately establish procedures for corrective and preventive action; * failing to adequately establish procedures for receiving,
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