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
Devices
FDA has released the FDA-483 issued following a 10/2-10/16/17 inspection at Zimmer Biomet’s manufacturing facility in Warsaw, IN. Specific observations were: * failing to adequately establish procedures for corrective and preventive action; * failing to adequately establish procedures to control product that does not conform to
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
Devices
FDA has cleared an Empatica 510(k) for Embrace, a smart watch that monitors for seizures known as “grand mal” or “generalized tonic-clonic” seizures. Once detected, the watch sends an alert to summon a caregiver for help. The device measures multiple seizure indicators. It uses “electrodermal activity,” a signal
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
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Celltrion, Inc. Incheon, Republic of Korea (1/26): FDA inspected the firm 6/2017 and cited significant GMP violations for finished pharmaceuticals. For example, the firm failed to establish
FDA Policy/General
Federal Register notice: FDA has determined for patent extension purposes that the regulatory review period for Amgen’s Blincyto (blinatumomab) is 2,850days. Of this time, 2,774 days occurred during the testing phase and 76 days during the approval phase. Blincyto is indicated for treating Philadelphia chromosome-negative relapsed
FDA Policy/General
Federal Register notice: FDA has submitted to OMB a revised information collection entitled “Guidance for Industry: Expedited Programs for Serious Conditions — Drugs and Biologics (OMB Control Numbers 0910-0389 and 0910-0765).” To view the notice, click here.
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,
FDA Policy/General
Two stakeholders groups are recommending that FDA make changes to its 12/2017 draft guidance on clinical decision support (CDS) software. The Clinical Decision Support (CDS) Coalition says FDA should revise and re-issue the draft guidance on CDS that outlined forms of CDS that won’t be regulated based
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
FDA Policy/General
Federal Register notice: FDA has classified the percutaneous nerve stimulator for substance use disorders into Class 2 (special controls). The action is in response to a 3/2017 de novo request from Innovative Health Solutions for its NSS–2 Bridge device. It has identified the product as a device that
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Animal Drug Adverse Event Reporting and Recordkeeping — 21 U.S.C. 360b(l), 21 CFR 510.301, and 514.80 (OMB Control Number 0910–0284).” To view the notice, click here.
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