Drugs
FDA has issued a five-item Form FDA-483 after a 2/27-3/7 inspection of Rentschler Biopharma’s manufacturing facility in Baden-Wurttemberg, Germany found significant GMP deficiencies. For example, the inspection cited the firm’s procedures for preventing microbial contamination as being inadequate. Inspectors said the facility
Drugs
Buoyed by positive results from the Phase 3 TRAILBLAZER-ALZ 2 study showing that donanemab significantly slowed cognitive and functional decline in people with early symptomatic Alzheimer’s disease, Lilly says it anticipates a regulatory submission to FDA this quarter and will work with the agency to achieve the fastest
Drugs
FDA has published the International Conference for Harmonization (ICH) Q9(R1) guidance, Quality Risk Management, to offer a systematic approach to quality risk management that leads to better, more informed, and timely decisions. The document says it specifically provides guidance on the principles and some of the tools of quality
Drugs
FDA has published a guidance, Assessing User Fees Under the Prescription Drug User Fee Amendments of 2022, with information for stakeholders on the agency’s implementation of PDUFA 7 changes to the user fee program. The document describes the types of user fees authorized by PDUFA 7, how FDA determines
Biologics
Reps. Lori Trahan (D-MA) and Dan Crenshaw (R-TX) say they are concerned about FDA’s pace for authorizing and approving updated Covid-19 therapeutics. In a 5/3 letter to FDA commissioner Robert Califf, the two say that while FDA has modernized its process in the past for
Biologics
The Biotechnology Innovation Organization (BIO) says the scope of an FDA draft guidance on considerations for the design and conduct of externally controlled trials for drugs and biologics “is rather narrow, excluding aggregate-level data as well as hybrid designs using external controls to augment a randomized trial.” The BIO
Drugs
FDA has published the International Council for Harmonization M9 Biopharmaceutics Classification System-Based Biowaivers Questions and Answers guidance. The document has questions and answers covering the Introduction/Scope, Biopharmaceutics Classification of the Drug Substance, Eligibility of a Drug Product for a BCS-Based Biowaiver, and an annex with questions and
Drugs
More than 250 Democrat members of Congress have signed an amicus brief to the 5th Circuit Court of Appeals urging it to reverse a Texas federal court ruling prohibiting FDA from allowing the sale of the abortion drug mifepristone. The members wrote the district court decision has no basis in
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says artificial intelligence (AI) presents many opportunities for industry and it supports FDA’s application of a “risk-based regulatory framework to the use of AI technologies in drug manufacturing.” In just-posted comments to the agency about a recent discussion paper on
Drugs
Some 10% of accelerated approval drugs are subsequently withdrawn and that number may continue to grow as FDA emphasizes the need to ensure a higher level of safety and efficacy for accelerated approval drugs by more closely scrutinizing the approval process. That’s the view of attorneys Dominick DiSabatino and
Drugs
An 8/23-9/2/22 FDA inspection at the Accra-Pac drug manufacturing facility, doing business as Voyant Beauty in Elkhart, IN, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 4/20 Warning Letter says specific violations were: * failing to thoroughly investigate any
Biologics
FDA has published a draft guidance, Decentralized Clinical Trials for Drugs, Biological Products, and Devices, with recommendations for sponsors, investigators, and other stakeholders on the implementation of decentralized clinical trials (DCTs) for drugs, biological products, and medical devices. The document defines a decentralized clinical trial as one in which some
Drugs
Vanda Pharmaceuticals is charging that FDA disclosed trade secrets from NDAs for the company’s Fanapt (iloperidone) and Hetlioz (tasimelteon) to companies submitting ANDAs for approval to market generic forms of the two drugs. In a 5/1 case filed with the United States Court of Federal Claims, Vanda says
Drugs
FDA posted 5/2 five additional deemed final orders, completing the process of posting 33 deemed final orders for 32 different monograph therapeutic categories and one for non-monograph conditions as part of over-the-counter drug monograph reform under the CARES Act. All of the deemed final orders are
Drugs
FDA has placed a partial clinical hold on Sun Pharma’s Deuruxolitinib (CTP-543), a JAK inhibitor being evaluated for treating alopecia areata, after reporting a serious adverse event (pulmonary embolism) that occurred in a patient taking a 12 mg BID dose in a long-term open label extension study.
Drugs
Astellas Pharma and Pfizer say they will discuss with FDA the filing of a supplemental NDA for Xtandi (enzalutamide) plus leuprolide for use in men with non-metastatic hormone-sensitive prostate cancer. The potential submission would be based on just-announced data showing the combination therapy significantly reduced the risk
Drugs
FDA has accepted for priority review a Bristol Myers Squibb supplemental BLA for Reblozyl (luspatercept-aamt) that seeks an expanded indication to include treating anemia without previous use of erythropoiesis-stimulating agents (ESA-naïve) in adult patients with very low- to intermediate-risk myelodysplastic syndromes (MDS) who may require blood
Drugs
Representatives Sara Jacobs (D-CA) and Cory Mills (R-FL) have introduced bipartisan legislation to minimize and prevent future drug shortages. The lawmakers says their Drug Shortage Prevention Act was drafted in response to shortages of children’s Tylenol and Motrin over the past few months. It would require manufacturers
Drugs
FDA has issued Ascendis Pharma a complete response letter on its NDA for TransCon PTH (palopegteriparatide), indicated for treating adults with hypoparathyroidism. The agency letter cited manufacturing control strategy concerns related to the variability of the delivered dose in the drug/device combination product, according to the company. FDA did
Drugs
FDA has issued Eli Lilly a three-item Form FDA-483 after aseptic processing deficiencies were identified during a 10/17-21/2022 inspection at the Lilly Technology Center in Indianapolis, IN. The heavily redacted inspection form cited the firm’s “deficient” aseptic technique associated with a drug product filling
Drugs
FDA has released a final guidance on Smoking Cessation and Related Indications: Developing Nicotine Replacement Therapy (NRT) Drug Products. The agency says the guidance includes “several innovations in the regulatory pathway for NRT drug products. For example, the guidance discusses ‘reduction in risk of relapse’ as a potential indication to
Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is planning a direct-to-consumer drug advertising survey to understand the tradeoffs made by diagnosed consumers and how those tradeoffs differ from the tradeoffs made by physicians on the drugs to use/prescribe. “The proposed research examines the relative importance of