Wednesday, September 18, 2019
Tuesday, September 17, 2019
Monday, September 16, 2019
KRS Global Biotechnology, Inc. Issues Voluntary Nationwide Recall of All Human and Animal Sterile Drug Products Due to Lack of Assurance of Sterility
Thursday, September 12, 2019
Thursday, September 12, 2019
An Ipca Labs plant savaged in an FDA warning letter three years ago continues to fail manufacturing standards that would assure its drugs are safe, which the FDA says is “demonstrated by a cascade of failure” in the quality unit o
Wednesday, September 11, 2019
Feds Warns CBD Marketers Again — Pain News Network: By Pat Anson, PNN Editor The Federal Trade Commission (FTC) has warned three companies that sell cannabidiol (CBD) oils, tinctures, edibles and other products to stop making claims that CBD can be used to treat pain and other chronic illnesses. In letters to the companies, which the FTC is not id
Trump Administration Combating Epidemic of Youth E-Cigarette Use with Plan to Clear Market of Unauthorized, Non-Tobacco-Flavored E-Cigarette Products FDA compliance policy would prioritize enforcement of premarket authorization requirements for non-tobacco-flavored e-cigarettes
Hospira, Inc., Issues A Voluntary Nationwide Recall for one lot of BACTERIOSTATIC WATER for Injection, USP, due to a Potential Lack of Sterility Assurance
OWNERS OF PASCO MARKETING FIRM PLEAD GUILTY TO HEALTHCARE-RELATED PLOT TBadmin | September 11, 2019: They used profits from the conspiracy to buy, among other things, luxury cars, including a Bentley Continental; a Lamborghini Aventador; a Maserati, and a Fisker Karma, according to the U.S. Attorney’s Office.
United States: Recent Traction In FDA's Development Of The 503A And 503B Bulks Lists Last Updated: September 11 2019 Article by Rachael G. Pontikes and Kelly A. Kearney Reed Smith
Law360 (September 11, 2019, 2:37 PM EDT) -- Just as the U. S. Food and Drug Administration promised https://www.law360.com/health/articles/1197546/fda-bulk-drug-list-updates-could-lead-to-litigation
Tuesday, September 10, 2019
Monday, September 9, 2019
Hearing delayed for Ruidoso trainer accused of doping; here's how the drugs affect horses Pamela L. Bonner, Ruidoso NewsPublished 7:00 a.m. MT Sept. 6, 2019 Performance-enhancing drugs like Albuterol often mask pain, allowing horses to race and train with injuries that would otherwise be too painful to run on, experts say.
September 9, 2019 Improving Adverse Event Reporting for Compounded Drugs Julie Dohm, JD, PhD1; Jenny Kim, PharmD, BCPS1; Janet Woodcock, MD1
JAMA Intern Med. Published online September 9, 2019. doi:10.1001/jamainternmed.2019.3830
During a routine inspection unrelated to compounded drugs, US Food and Drug Administration (FDA) investigators found records of 4202 adverse events, none of which had ever been reported to the agency.1 The reports, kept in a company-generated data file, concerned the possible association of compounded hormone pellets marketed by BioTE Medical (BioTE) with cancers (including endometrial and prostate cancers), strokes, heart attacks, deep vein thrombosis, cellulitis, and pellet extrusions, as well as adverse events known to be caused by supratherapeutic hormone concentrations.
The U.S. Department of Health and Human Services Office for Human Research Protections (OHRP) is hosting its 2nd Annual Exploratory Workshop on September 19, 2019. The title of the Workshop is Privacy and Health Research in a Data-Driven World. It will be webcast live and recorded, and is available free of charge.
The Workshop will explore issues around conceptions of privacy, ways to protect data confidentiality, and how IRBs and review bodies can learn more about protections and ethical oversight of important research.
Sessions will include:
• Is Privacy a Casualty of Advancing Research?
• Approaches to Protecting Privacy and Confidentiality
• Protecting Privacy and Confidentiality: A Shared Responsibility
For the draft agenda and more information, please see: https://www.hhs.gov/
ohrp/education-and-outreach/ exploratory-workshop/2019- workshop/index.html
Thursday, September 5, 2019
Wednesday, September 4, 2019
To clarify portions of yesterday’s email blast titled “USP 800:”
- None of the Rules in the 2019 Rule revisions are in effect.
- They were not published in the Oklahoma Administrative Code as required by the Oklahoma Rules on Rule making - which makes them null and void.
- The Board plans to take new Rulemaking action before the next legislative session.
The Rules provided in the link included in yesterday's email are NOT IN EFFECT.
Tuesday, September 3, 2019
FDA in Brief: FDA seeks comment on its preliminary finding that there ...
https://www.fda.gov › news-events › fda-brief › fda-brief-fda-seeks-comm...
5 days ago - FDA in Brief: FDA seeks comment on its preliminary finding that there is no clinical need for outsourcing facilities to compound drugs using nine bulk drug ...