Drugs
Washington Legal Foundation (WLF) is asking the Supreme Court to review and then overturn an appeals court decision authorizing private individuals to sue drug companies for government-contracting fraud based on technical violations of federal regulations, even if FDA approved the drugs and government officials continue to buy them after
Drugs
FDA has updated a public listing of “Pharmacogenomic Biomarkers in Drug Labeling.” The listing details the data in labeling that can help identify responders and non-responders to medications, avoid adverse events, and optimize drug doses. “The labeling for some, but not all, of the products includes specific actions to
Drugs
Four stakeholders are praising FDA’s 1/16 notification of an indefinite delay in the effective date of a final rule setting forth a new method for determining the intended use of medical products. The stakeholders say the delay is warranted given the controversy over a provision in the rule
Drugs
FDA has posted online “Considerations for Applicants Deciding When to Submit Elemental Impurity Data to FDA” recommending that any applicant who has not fully addressed elemental impurities in their applications in their current form submit the information as soon as possible. “If the application is currently under review,” the post
Drugs
FDA will soon unveil a comprehensive plan to promote more competition and availability of biosimilars, according to commissioner Scott Gottlieb. During a 2/6 address to the Alliance for a Stronger FDA, Gottlieb expressed the agency’s dissatisfaction with how its biosimilars program has progressed and its small impact on
Drugs
A New York federal court has finally ruled on a 2012 motion to dismiss a suit based on earlier Supreme Court rulings in Mensing and Bartlett. Attorney Michelle Yeary (Dechert) writes in an online blog post that the suit alleged the plaintiff suffered from Stevens Johnson Syndrome as a result
Drugs
As required under the 2012 FDA Safety and Innovation Act, FDA has submitted to Congress its report on the Governing Antibiotic Incentives Now (GAIN) law addressing the public health threat of antibacterial drug resistance by stimulating the development and approval of new antibacterial and antifungal drugs. The document describes these
Drugs
FDA has issued a guidance on “Microbiology Data for Systemic Antibacterial Drugs — Development, Analysis, and Presentation.” The document provides agency recommendations on the overall microbiology development program needed to support clinical development and approval of antibacterial drugs administered systemically as well as microbiology information collected after approval. It replaces the
Drugs
Bristol-Myers Squibb (BMS) says that its ongoing Phase 3 CheckMate-227 study met its co-primary endpoint of progression-free survival (PFS) with the Opdivo (nivolumab) plus Yervoy (ipilimumab) combination versus chemotherapy in first-line advanced non-small cell lung cancer (NSCLC) patients whose tumors have high tumor mutation
Drugs
FDA has denied a fourth petition submitted by United Therapeutics Corp. asking that the agency not approve any ANDA for a treprostinil inhalation solution drug-device combination product referencing its Tyvaso (treprostinil) inhalation solution unless the ANDA meets four requirements specified by the petition. FDA denied the petition without comment
Drugs
FDA researchers have told an American Association of Pharmaceutical Scientists (AAPS) webinar that simulations based on branded drugs’ FDA-submitted data and limited use of a generic are adequate and can help shorten generic drug-device combination development timelines. An AAPS online post says the researchers described their work using
Drugs
A 5/22-6/2/17 FDA inspection at Celltrion, Inc., Incheon, Korea, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 1/26 Warning Letter. Specific violations cited were: * failing to establish and follow appropriate written procedures that are designed to prevent
Drugs
A 9/11-9/15/17 FDA inspection at Polaroisin International, New Taipei City, Taiwan, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, according to a 1/25 Warning Letter. Specific violations cited were: * failing to have, for each batch of drug product, appropriate laboratory
Drugs
FDA says it will hold a 5/24 public workshop to provide an overview of the current status of the regulatory science initiatives for generic drugs and to provide an opportunity for public input on research priorities in those topic areas. The workshop announcement says the agency is seeking input
Drugs
FDA has awarded Octo Consulting a $300 million seven-year contract to meet 21st Century Cures Act requirements to develop a more efficient and streamlined drug and medical device approval process. A company announcement says Octo was chosen by CDER “to support a comprehensive suite of strategic capabilities and processes,
Drugs
New FDA research provides even stronger evidence of abusable kratom compounds’ opioid properties, according to agency commissioner Scott Gottlieb. In an online statement, Gottlieb says many questions have been raised in recent months about this botanical substance, which has been associated with 44 deaths in the U.S. so far.
Drugs
FDA says a recent guidance on Good ANDA Submission Practices helps generic drug manufacturers obtain faster approvals by submitting more complete ANDA applications. A 2/6 CDER Small Business and Industry Assistance podcast says that until now, half of all ANDAs with GDUFA review goals required at least three review
Drugs
FDA has posted a Form 483 from a 1/24-completed inspection of Houston, TX-based Empower Pharmacy that cites a repeat observation from an earlier inspection — failure to thoroughly investigate any unexplained discrepancy or failure of a batch, regardless of whether the batch has been distributed, or a failure
Drugs
Consumer-health advocacy group Citizens for Health has urged FDA commissioner Scott Gottlieb to remove a Pew Charitable Trusts representative from the agency’s Pharmacy Compounding Advisory Committee (PCAC) due to alleged conflicts of interest in Pew’s lobbying support for pharmaceutical company interests. PCAC was created in 2014 and
Drugs
FDA is reminding all ANDA and NDA holders about a one-time report that is due 2/14 on the market status for all approved drug products. The report is mandated in the recently enacted FDA Reauthorization Act of 2017 under Section 506I, which calls on all NDA and ANDA
Drugs
CDER and CBER have released their “Data Standards Strategy FY2018-FY2022” that commits the Centers to continue the development, implementation, and maintenance of a comprehensive data standards program that will facilitate the pre- and post-market regulatory review process. “Together the two Centers will leverage their combined resources, talent and
Drugs
FDA has approved an Amag Pharmaceuticals supplemental NDA to broaden the existing label for Feraheme (ferumoxytol injection) beyond the current chronic kidney disease indication to include all eligible adult iron deficiency anemia patients who have intolerance to oral iron or have had unsatisfactory response to oral iron. Approval was based