FDA Policy/General
FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter. Essential Pharmaceutical, Pomona, CA (9/3): FDA inspected the firm 10/2019 and found that the company produces adulterated and misbranded dietary supplements as well as an unapproved new
FDA Policy/General
Federal Register notice: FDA has announced the fee rate for using a material threat medical countermeasure priority review voucher for fiscal year 2021. The fee amount is $1,360,879 and it must be submitted with a priority review voucher for a human drug application, in addition to any Prescription
FDA Policy/General
Federal Register notice: FDA has revoked the Emergency Use Authorizations issued to Autobio Diagnostics for the Anti-SARS-CoV–2 Rapid Test because of poor device performance. To view the notice, click here.
FDA Policy/General
CDER’s Office of Prescription Drug Promotion (OPDP) has issued Nalpropion Pharmaceuticals a Warning Letter about a sponsored link appearing on Google’s search engine for Contrave (naltrexone hydrochloride and bupropion hydrochloride), citing the company for false or misleading claims about the risks associated with the drug’s efficacy. “These
FDA Policy/General
Federal Register notice: FDA has postponed until further notice a 10/7 meeting of its Medical Devices Advisory Committee’s Circulatory System Devices Panel, which was scheduled to discuss a TransMedics PMA for its Organ Care System — Heart. The portable ex-vivo organ perfusion and monitoring system is indicated for
FDA Policy/General
Nephron Pharmaceuticals has been issued what looks to be the first Warning Letter to cite a prescription drug manufacturer for promoting its product for an unapproved use in treating Covid-19. The letter from CDER’s Office of Prescription Drug Promotion (OPDP) cited emails about Nephron’s budesonide inhalation suspension
FDA Policy/General
Accredited Persons Inspection Program Info Collection Federal Register notice: FDA sends to OMB an information collection extension for its device accredited persons inspection program. 07/19/2019 FDA Adopts Geopolitical Naming/Coding Standard Federal Register notice: FDA announces that it will adopt the current version of the Geopolitical Entities, Names,
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Opioid Use Disorder: Endpoints for Demonstrating Effectiveness of Drugs for Treatment. The document addresses comments received after an 8/7/2018 draft guidance was released. To view the notice, click here.
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection revision for “Orphan Drugs; 21 CFR Part 316” (OMB Control Number 0910-0167). The collection is being revised to include Guidance for Industry, Researchers, Patient Groups, and Food and Drug Administration Staff on Meetings With the Office of Orphan
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Bladder Cancer: Developing Drugs and Biologics for Adjuvant Treatment. The document provides recommendations to sponsors on eligibility criteria, choice of comparator, follow up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results.
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Renal Cell Carcinoma: Developing Drugs and Biologics for Adjuvant Treatment. The document includes recommendations on eligibility criteria, choice of comparator, follow-up imaging assessments, determination of disease recurrence, analyses of disease-free survival, and interpretation of trial results. To
FDA Policy/General
FDA has renewed and expanded its licenses of Certara’s biosimulation software with more than 400 user licenses of the company’s Simcyp and Phoenix platforms. A company announcement says 11 FDA divisions and offices use the Certara software for internal research and to independently analyze, verify, and review regulatory
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled The Use of Physiologically Based Pharmacokinetic Analyses — Biopharmaceutics Applications for Oral Drug Product Development, Manufacturing Changes, and Controls. The document provides general recommendations about the development, evaluation, and use of physiologically based pharmacokinetic analyses for biopharmaceutics applications used in
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled E14 and S7B Clinical and Nonclinical Evaluation of QT/QTc Interval Prolongation and Proarrhythmic Potential — Questions and Answers. The document contains revised and new questions and answers on evaluating QT/QTc interval prolongation and proarrhythmic potential in non-antiarrhythmic
FDA Policy/General
Writing in a Washington Post op-ed, seven former FDA commissioners warn that the perception of political influence in FDA’s science-based decisions matters and say “political intrusion only prolongs the pandemic and erodes our public health institutions.” The op-ed was signed by Robert Califf, Scott Gottlieb, Margaret
FDA Policy/General
Federal Register notice: FDA has announced an amendment to a 10/22 Vaccines and Related Biological Products Advisory Committee meeting. The “address” portion of the earlier document is changed to read as follows: “The online Web conference meeting will be available at the following link: http://fda.yorkcast.com/webcast/
FDA Policy/General
Federal Register notice: FDA has announced a 10/6 public meeting entitled “Patient-Focused Drug Development for Stimulant Use Disorder” that was originally scheduled to occur 3/10. The purpose is to obtain stakeholder perspectives on the impact of stimulant use disorder and views on treatment approaches for stimulant use
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled M7 Assessment and Control of DNA Reactive (Mutagenic) Impurities in Pharmaceuticals To Limit Potential Carcinogenic Risk — Questions and Answers. The document provides a practical approach that is applicable to the identification, categorization, qualification, and control of mutagenic impurities to
FDA Policy/General
Federal Register notice: FDA has made available a draft guidance entitled Failure to Respond to an ANDA Complete Response Letter Within the Regulatory Timeframe. The document is intended to assist applicants in responding to ANDA complete response letters. In addition, this guidance recommends information an applicant may submit in its
FDA Policy/General
Federal Register notice: FDA has made available a final guidance entitled Breast Implants — Certain Labeling Recommendations to Improve Patient Communication. The document contains recommendations on the content and format for certain labeling information for saline and silicone gel-filled breast implants. To view the notice, click here.
FDA Policy/General
Former FDA principal deputy commissioner Joshua Sharfstein and two other researchers say “FDA should look to increase transparency and maximize public trust in its integrity.” Writing in a Stat online opinion column, the three offer four ways in which the agency could increase transparency. They start their column by discussing
FDA Policy/General
Federal Register notice: FDA is seeking comments on an information collection extension for “Generic Clearance for the Collection of Qualitative Data on Tobacco Products and Communications” (OMB Control Number 0910-0796). The collection supports studies relating to the regulation and communications related to tobacco products, including qualitative research through focus