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
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
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,
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
Drugs
FDA acting commissioner Janet Woodcock says she believes the nation’s clinical trial network might work best if drug companies remained more outside a revised network framework. In an interview printed online in Outsourcing Pharma, Woodcock says she has “always thought we should have independent people running the trial networks
Drugs
FDA has issued a final guidance entitled Bispecific Antibody Development Programs that provides recommendations for specific regulatory, quality, nonclinical, and clinical considerations for such development programs. The document also clarifies quality, nonclinical, and clinical considerations when developing bispecific antibodies. The agency says that many aspects of a bispecific antibody development
Drugs
CDER says it will apply an intense focus to encourage the pharmaceutical industry to achieve “quality management maturity.” Delivering a Center update at the Food and Drug law Institute’s annual meeting 5/21, CDER director Patrizia Cavazzoni said that despite the overwhelming pandemic-related ongoing work, product quality remains
Drugs
FDA has approved a Janssen Pharmaceutical NDA for Rybrevant (amivantamab-vmjw) for treating adult patients with non-small cell lung cancer whose tumors have specific types of genetic mutations — epidermal growth factor receptor (EGFR) exon 20 insertion mutations. The agency also approved Guardant Health’s Guardant360 CDx as a companion
Drugs
Federal Register notice: FDA has made available a draft guidance entitled ICH Q12: Implementation Considerations for FDA-Regulated Products. The document helps U.S.-regulated firms implement an International Council for Harmonization guidance entitled Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management and its annexes. It also includes
Drugs
FDA has accepted for priority review a BeiGene supplemental NDA for Brukinsa (zanubrutinib) for treating adult patients with marginal zone lymphoma (MZL) who have received at least one prior anti-CD20-based therapy. The agency set a 9/19 user fee action target date. The submission is based on data
Drugs
FDA’s adapting to the Covid-19 pandemic led to quicker and greater acceptance of real-world evidence, which has now led to the recognition that certain practices will be useful in this post-pandemic space. Speaking at the Food and Drug Law Institute’s annual meeting 5/20, CDER
Drugs
FDA has published a draft guidance, Adjusting for Covariates in Randomized Clinical Trials for Drugs and Biologics, to provide recommendations for using covariates in the analysis of randomized, parallel-group clinical trials that apply to both superiority trials and non-inferiority trials. The document says its main focus is on
Drugs
FDA has published a draft guidance, Information Sheet Guidance for Sponsors, Clinical Investigators, and IRBs: Frequently Asked Questions Statement of Investigator (Form FDA-1572) (Revision 1), describing how to complete FDA-1572 for clinical investigations conducted under IND regulations. The document partially revises a 5/2010 FDA-1572 FAQ (frequently
Drugs
FDA has extended to 10/17 the PDUFA target action date for Omeros’ BLA for narsoplimab to treat hematopoietic stem cell transplant-associated thrombotic microangiopathy. The company says that as part of the BLA priority review, it submitted a response to an FDA information request that the agency classified as
Drugs
FDA has published a guidance, ANDAs for Certain Highly Purified Synthetic Peptide Drug Products That Refer to Listed Drugs of rDNA Origin, to assist potential applicants in determining when an application for a synthetic peptide that refers to a previously approved peptide drug product of rDNA origin should be submitted