FDA Policy/General
Rep. Raja Krishnamoorthi (D-IL) says that science shows that e-cigarette users are much more likely to be diagnosed with Covid-19 and to experience symptoms. Krishnamoorthi discussed the finding in an 8/11 letter to FDA commissioner Stephen Hahn. In the letter, the representative said he had presented
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Taka USA, Carrollton, TX (7/29) FDA inspected the company 6/2019 and cited significant GMP violations for finished pharmaceuticals. For example, Taka failed to have for each batch
FDA Policy/General
Federal Register notice: FDA announces an 8/31 online Pulmonary-Allergy Drugs Advisory Committee meeting. Panel members are scheduled to a discuss a GlaxoSmithKline supplemental NDA for Trelegy Ellipta (fluticasone furoate, umeclidinium, and vilanterol inhalation powder oral inhalation), indicated for reducing all-cause mortality in patients with chronic obstructive pulmonary
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled “Drug-Drug Interaction Assessment for Therapeutic Proteins.” The document is intended to provide a systematic, risk-based approach to help sponsors determine the need for drug-drug interaction studies for a therapeutic protein. To view the notice, click here.
Drugs
California has reached a settlement agreement with AbbVie Inc. to resolve a lawsuit alleging violations of the California Insurance Frauds Prevention Act involving the marketing of Humira (adalimumab), indicated for treating arthritis, plaque psoriasis, ankylosing spondylitis, Crohn’s disease, and ulcerative colitis. “AbbVie agreed to reform its Humira marketing practices
FDA Policy/General
Federal Register notice: FDA has made available an annual report entitled “Report on the Performance of Drug and Biologics Firms in Conducting Postmarketing Requirements and Commitments.” To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Limited Population Pathway for Antibacterial and Antifungal Drugs.’’ The document provides information on implementing the pathway which is a provision of the 21st Century Cures Act. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection entitled “Extralabel Drug Use for Animals — 21 CFR 530” (OMB Control Number 0910–0325). The collection supports FDA’s requirement that an analytical method be developed for detecting residues from the extralabel use of a drug. To view the
FDA Policy/General
Federal Register notice: FDA has submitted to OMB an information collection extension for “Postmarketing Information Sharing Among Constituent Part Applicants for Combination Products — 21 CFR 4.103” (OMB Control Number 0910–0834). Under the collection, constituent part applicants must share safety information they receive related to certain events with the
FDA Policy/General
Federal Register notice: FDA is seeking applicants to participate in an Office of Combination Products (OCP) voluntary pilot program to help it evaluate a new electronic submissions process for Requests for Designation (RFD) and Pre-RFD. OCP plans to accept up to nine participants for the pilot program. To view
FDA Policy/General
Federal Register notice: FDA has announced fiscal year 2021 user fee rates for the establishment and re-inspection fees related to entities that compound human drugs and elect to register as outsourcing facilities. For example, the non-small business establishment fee is $18,837, and the re-inspection fee for
FDA Policy/General
Federal Register notice: FDA has announced the rates for generic new animal drug user fees for fiscal year 2021. For example, the fee for an abbreviated application for a generic new animal drug is $513,000, and the generic new animal drug sponsor fee is $202,000. To view the
FDA Policy/General
Federal Register notice: FDA has announced the fee rates and payment procedures for fiscal year 2021 animal drug user fees. For example, the New Animal Drug Application fee is set at $575,000 and the Supplemental Animal Drug Application fee is $287,000. To view the notice, click here.
FDA Policy/General
FDA says its 6/2020 review of the Web site operated by Fishman Chemical of North Carolina, Vero Beach, FL, found that the company sells 11 unapproved new animal drugs. A 7/21 Warning Letter also says the company is continuing to sell chloroquine phosphate, an adulterated new animal drug,
FDA Policy/General
Federal Register notice: FDA is requesting comments on abuse potential, actual abuse, medical usefulness, trafficking, and impact of scheduling changes on the availability for medical use of 11 drug substances. The comments will be considered in preparing a response from the U.S. to the World Health Organization (WHO) regarding
FDA Policy/General
Federal Register notice: FDA has announced the rates for biosimilar user fees for fiscal year 2021. For example, the fee for a biosimilar application requiring clinical data is $1.7 million, and the initial biological product development fee is $102,000. To view the notice, click here.
FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Acrx Specialty Pharmacy, Las Vegas, NV (7/24): FDA inspected the firm in March and found multiple violations of drug compounding and other provisions of the Federal Food, Drug,
FDA Policy/General
Federal Register notice: FDA has announced the rates for prescription drug user fees for fiscal year 2021. For example, fee for NDA/BLA requiring clinical data $2.9 million, NDA/BLA not requiring clinical data $1.4 million and the program fee is set at $336,000. To view the
FDA Policy/General
Federal Register notice: FDA has announced the fee rates and payment procedures for medical device user fees for fiscal year 2021. For example, PMA user fees are set at $365,000, 510(k) fee $12,400 and annual establishment registration fee $5,500. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled “Pediatric Study Plans: Content of and Process for Submitting Initial Pediatric Study Plans and Amended Initial Pediatric Study Plans.” The document addresses FDA’s current thinking on implementing the requirement for sponsors to submit a pediatric study plan. To
FDA Policy/General
Federal Register notice: FDA has made available guidance documents related to Covid–19 public health emergency. The documents have been implemented without prior comment, but they remain open for comments in accordance with the agency’s good guidance practices. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on a report entitled “Independent Evaluation of the GDUFA Resource Capacity Planning Adjustment Methodology.” The report, which was mandated in the Generic Drug User Fee Amendments of 2017, provides options and recommendations for a new methodology to assess changes in the resource needs