Devices
FDA has issued two draft guidances on the continuous surveillance of certain approved and cleared devices. The first draft, Postmarket Surveillance Under Section 522 of the Federal Food, Drug, and Cosmetic Act, will assist medical device manufacturers subject to Section 522 postmarket surveillance orders by providing (1) an overview of
FDA Policy/General
Federal Register notice: FDA is announcing the availability of FDA guidance documents related to the Covid-19 pandemic. The documents have been implemented without prior comment, but they remain subject to comment under the agency’s good guidance practices. They are: * Development of Abbreviated New Drug Applications During the COVID-
FDA Policy/General
Federal Register notice: FDA is updating its administrative records to reflect two Emergency Use Authorizations (EUAs) (XXX PLURAL XXX)for biological products for use during the Covid-19 pandemic. On 2/9, an EUA was granted to Eli Lilly for bamlanivimab and etesevimab combination use, and on 2/27, an
Drugs
FDA says it is restricting the use of Intercept Pharmaceuticals’ Ocaliva (obeticholic acid) in patients having primary biliary cholangitis (PBC) with advanced cirrhosis of the liver because it can cause serious harm. An agency drug safety communication says some PBC patients who took Ocaliva, especially those with evidence of advanced
Drugs
FDA says it is withdrawing a “legally and factually inaccurate notice and request for information” that the Trump administration HHS published 11/25/20 to terminate FDA’s unapproved drug initiative (UDI). A sharply worded Federal Register notice signed by FDA acting commissioner Janet Woodcock says the HHS notice contained
Drugs
FDA has placed a clinical hold on the Larimar Therapeutics clinical program for its CTI-1601, a recombinant fusion protein intended to deliver human frataxin into the mitochondria of patients with Friedreich’s ataxia who are unable to produce enough of the protein. The company says the hold follows its
Biologics
FDA has updated its guidance on Emergency Use Authorization (EUA) for Vaccines to Prevent Covid-19 to include a new section that says the agency may decline to review and process further EUA requests other than those for vaccines whose developers have already engaged with the agency. “Additionally, given the
Drugs
After a pre-NDA meeting with FDA, Travere Therapeutics says the agency believes that data from the ongoing Phase 3 DUPLEX study of sparsentan for treating focal segmental glomerulosclerosis (FSGS) are not adequate to support accelerated approval. Based on the agency’s feedback, the company no longer expects to submit
Drugs
FDA has denied a Vifor Fresenius 4/15/16 petition asking the agency to recognize that Velphoro (sucroferric oxyhydroxide) is eligible for five-year new chemical entity (NCE) exclusivity based, among other things, on an assertion that Velphoro does not contain a previously-approved active ingredient. The petition also asked
Drugs
FDA and the Federal Trade Commission have sent Warning Letters to five companies for illegally selling unapproved new drugs as dietary supplements claiming to cure, treat, mitigate, or prevent infertility and other reproductive health disorders. An FDA media release says the warnings went to LeRoche Benicoeur/Conceive Easy, EU Natural
Drugs
FDA has approved a Myovant Sciences and Pfizer NDA for Myfembree (relugolix 40 mg, estradiol 1 mg, and norethindrone acetate 0.5 mg) for managing heavy menstrual bleeding associated with uterine fibroids in premenopausal women. Approval was based on data from the Phase 3 LIBERTY 1 and LIBERTY 2 studies,
Drugs
FDA has released the FDA-483 issued following a 12/9/19-1/17/20 inspection at the Hospira sterile drug manufacturing facility in McPherson, KS. The 10 inspection observations on the form were: * failing to fully follow the responsibilities and procedures applicable to the quality control unit; * failing to
Drugs
An FDA review of records submitted at the agency’s request by Biotek India, Gujarat, India, and other information has identified significant violations of current good manufacturing practice (CGMP) regulations. A 5/13 Warning Letter says the violations are: * failing to have for each batch of drug product appropriate laboratory
Drugs
FDA says its review of a Web site and social media sites maintained by Smart Women’s Choice, La Jolla, CA, indicate that the company markets its Smart Women’s Choice vaginal contraceptive cream that is legally considered to be a drug because it is intended for use in the
FDA Policy/General
Federal Register notice: FDA has determined that Abraxis Pharmaceutical’s injectable manganese sulfate 0.1 mg/mL was not withdrawn due to safety or effectiveness reasons. The determination will allow FDA to approve ANDAs that reference the product if all other legal and regulatory requirements are met. The drug is
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Bispecific Antibody Development Programs. The document focuses on general regulatory and scientific considerations for bispecific antibodies, but not on development of a particular bispecific antibody. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection revision on “Shortages Data Collections” (OMB Control Number 0910-0491). The collection supports CDRH activities related to essential medical device shortages. The revision adds information required by Section 3121 of the CARES Act. To view the notice, click here.
Drugs
With several sources worldwide declaring 4/2020 that South Korea’s Covid-19 response strategy had successfully “flattened the curve” of the disease, FDA says that country’s experience may be informative for future considerations. The agency has issued a report that particularly examines South Korea’s approaches to development,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled FDARA Implementation Guidance for Pediatric Studies of Molecularly Targeted Oncology Drugs. The document addresses early planning for pediatric evaluation of certain molecularly targeted oncology drugs and biological products. FDA says the early pediatric evaluation of certain molecularly targeted oncology
Drugs
FDA says Provention Bio’s teplizumab Type 1 diabetes treatment successfully demonstrated its treatment effect in delaying diagnosis of Type 1 diabetes in at-risk patients. The assessment is in a briefing document released by the agency in advance of the 5/27 meeting of the Endocrinologic and Metabolic Drugs
Devices
FDA has cleared a ChoiceSpine 510(k) for the Blackhawk Ti Cervical Spacer System. The 3D-printed device is made using the company’s BioBond porous titanium technology, according to ChoiceSpine. It also features a large open graft window for bone graft containment and maximum visualization, and a simultaneous, single-
FDA Policy/General
The Pew Charitable Trusts says an FDA concept paper, Potential Approach for Defining Durations of Use for Medically Important Antimicrobial Drugs Intended for Use In or On Feed: A Concept Paper, “is substantially flawed and will require significant revision.” In a just-released 4/12 comment letter, Pew says the