Drugs
AbbVie has submitted a supplemental NDA for Vraylar (cariprazine) for the adjunctive treatment of major depressive disorder in patients who are receiving ongoing antidepressant therapy. The submission is based on data from a Phase 3 study that showed a clinically and statistically significant change from baseline to week six in
Drugs
FDA says it intends to engage in notice-and-comment rulemaking on statutory provisions about certain distributions of compounded human drugs and a standard memorandum of understanding (MOU) between the agency and states. An online notice says the need for rulemaking came in 10/2020 when FDA was sued in
Drugs
CDER has announced a 4/13 Webinar entitled “Biosimilars: A Decade of Experience and Future Directions—Strategies for Improving Biosimilar Adoption and the Potential Role of Clinical Pharmacology.” The program is being presented by CDER’s Office of Clinical Pharmacology and the University of Maryland’s Center of Excellence in
Drugs
Ferring Pharmaceuticals is asking FDA to put restrictions on any section 505(j) ANDA and 505(b)(2) NDA citing the company’s Firmagon (degarelix acetate) for subcutaneous injection to treat patients with advanced prostate cancer. In a 2/9 petition, Ferring asks for a determination that any generic ANDA
Drugs
FDA says its approval of a generic diclofenac sodium topical gel 1% was the first ANDA approval for which a physiologically based pharmacokinetic (PBPK) model supported the bioequivalence assessment. An agency paper says CDER researchers have been investigating how pharmacokinetic modeling can support a bioequivalence determination for topical drug products.
Drugs
What is believed to be the first reported survey on views of the U.S. public on FDA transparency shows that the public would like to see much more transparency from the agency. Researchers from Johns Hopkins University write in a JAMA open access article that they asked a representative
Drugs
Former CDER Office of Cardiology, Hematology, Endocrinology, and Nephrology director Ellis Unger has joined Hyman, Phelps & McNamara as a principal drug regulatory expert. After 24 years at FDA, Unger retired from the agency last year to spend more time with family. He joined FDA in 1997 as a medical
Drugs
The CDER Office of Prescription Drug Promotion (OPDP) says a 9/22/21 video interview with the then-CEO of CytoDyn, Vancouver, WA, represented in a promotional context that leronlimab, an investigational new drug, is safe and effective for the purpose for which it is being investigated. Specifically, according to
Drugs
An 8/13-9/14/21 FDA inspection at Toxikon/Labcorp Bedford, Bedford, MA, conducted under the agency’s Bioresearch Monitoring Program, found violations of the Good Laboratory Practice regulations. A 2/10 Warning Letter says specific violations were: * failure of the study director to assure that all experimental data,
Drugs
A Natural Products Association petition to FDA asks the agency to stop excluding hemp-derived cannabidiol (CBD) from the definition of a dietary supplement. A Nutritional Outlook online post (includes a link to the petition) says the trade group specifically asks that FDA: * determine CBD is not excluded from the
Drugs
FDA has extended a clinical hold on BioMarin Pharmaceutical’s PHEARLESS Phase 1/2 study of BMN 307, an AAV5-human phenylalanine hydroxylase gene therapy being studied in adults with phenylketonuria. The trial has been on hold since 9/2021, and now FDA has requested data from additional non-clinical
Drugs
FDA will hold a 3/22 virtual public meeting to discuss the final assessment of the Program for Enhanced Review Transparency and Communication in BsUFA 2 (Biosimilars User Fee Act). An agency notice (includes links to interim assessment and registration information) says the program goal is to promote the efficiency
Drugs
FDA has published a new batch of product-specific guidances, including 30 new and 13 revised guidances that provide recommendations for developing generic drugs and generating the evidence needed to support ANDA approval. A Federal Register notice lists the drug products for which new product-specific guidances are available and
Drugs
Sen. Thom Tillis (R-NC) says some advocacy groups are using potentially inaccurate and false narratives to allege that drug companies misuse patent laws to delay generic competition and drive up prices. He has asked FDA and the U.S. Patent and Trademark Office (USPTO) to conduct an independent study
Drugs
FDA is backpedaling on new requirements for annual drug manufacturing reporting that were mandated by the CARES Act to help the agency get a handle on potential drug shortages. Last October, FDA announced the availability of a “NextGen Portal” for reporting the annual amount of listed human and animal drugs
Drugs
Acadia Pharmaceuticals has resubmitted a supplemental NDA for Nuplazid (pimavanserin) for treating hallucinations and delusions associated with Alzheimer’s disease psychosis (ADP). The move follows a 4/2/2021 FDA complete response letter that, at the time, the company said “cited a lack of statistical significance in some of the
Drugs
Members of the FDA Anesthetic and Analgesic Drug Products Advisory Committee and Drug Safety and Risk Management Advisory Committee voted 14-8 on 2/15 that Avenue Therapeutics did not submit adequate information to support its position that the benefits of IV tramadol outweighed its risks in managing acute pain
Drugs
Attorney Marc Ullman (Rivkin Radler) questions a push for mandatory dietary supplement listing with FDA in light of what he sees as the agency’s failure to enforce existing dietary supplement laws and regulations. In an online post for Natural Products Insider, Ullman writes that for at least eight years
Drugs
Two Dechert attorneys say the 9/2021 FDA “intended use” regulation should not keep companies from manufacturing more of a drug or medical device than they would need to meet the anticipated demand for on-label prescriptions because it was aware of off-label uses. Writing in a Washington Legal
Drugs
A pilot program that could improve drug development and approval for rare diseases is part of the performance goals outlined for the upcoming PDUFA reauthorization. Medill News Service reports the pilot would be expected to bolster clinical trials for rare diseases by increasing collaboration between industry and the agency to
Drugs
AstraZeneca says it “welcomes FDA’s provision of clear guidance on the inspection of injectable products for visible particulates.” The company’s response to an agency draft guidance on the topic also includes line-by-line specific comments. Boehringer Ingelheim’s response says the intent and overall goal of the
Drugs
FDA has accepted a Mirati Therapeutics NDA for adagrasib to treat patients with non-small-cell lung cancer with the KRASG12C mutation who have received at least one prior systemic therapy. The company says the PDUFA action date was set at 12/14. The NDA is being reviewed for accelerated