Ad Law Tool Kit Show – Episode 1 – Product Safety and Recalls
Foreign device manufacturers should anticipate greater chance of FDA inspection under new FDA leadership
ACI’s FDA Boot Camp – now in its 42nd iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under the Food and Drug Omnibus Reform Act (FDORA). This...more
ACI’s FDA Boot Camp is back in Boston! This essential training course – now in its 41st iteration – continues to provide the working knowledge of core essentials of FDA law and regulation, including the new amendments under...more
Earlier this year, the US Center for Disease Control and Prevention (“CDC”) spotted an outbreak of a rare bacterial infection in 11 (now 16) different states, associated with multiple different infection types, particularly...more
On March 22, 2023, at the request of the U.S. Food and Drug Administration (“FDA”), Ascend Laboratories LLC. (“Ascend”) issued a voluntary nationwide recall of certain lots of Dabigatran Etexilate Capsules, a blood thinner...more
In recent months, the Food and Drug Administration (FDA) announced several recalls related to natural supplements that were found to contain tadalafil and its analogs, the active ingredients in Viagra and Cialis. In its...more
Through nearly 19 years, ACI’s FDA Boot Camp has been the training grounds for life sciences attorneys and executives to master the fundamentals of FDA regulation. Don’t miss your opportunity to join their ranks....more
The U.S. Food and Drug Administration (FDA) recently issued final guidance regarding the initiation of voluntary product recalls “to help companies prepare to quickly and effectively remove violative products from the...more
ACI’s FDA Boot Camp returns in a completely interactive virtual format to help life sciences attorneys and executives to master the fundamentals of FDA Regulation... Gain essential working knowledge of core FDA concepts,...more
Chemical formula of Finasteride On May 12, 2020, MasterPharm, a compounding pharmacy based in New York, issued a recall of its popular hair regrowth formulation FinPlus. This medication, compounded by MasterPharm by...more
FDA Plans to Restart On-Site Inspections the Week of July 20 -Commissioner Hahn announced the goal of restarting inspections, which were halted due to COVID-19. The FDA has developed a COVID-19 Advisory Rating system to...more
For over 15 years, ACI’s FDA Boot Camp has been the Training Grounds for Life Sciences Attorneys and Executives to Master the Fundamentals of FDA Regulation. Now the conference returns for its 37th iteration, in a fully...more
It was no April Fool’s Day joke when the U.S. Food & Drug Administration (FDA) issued a news release requiring the recall of every single ranitidine drug on the market. Ranitidine, commonly known as Zantac, an...more
Previously, Drugs Manufactured by Outsourcing Facilities Were Largely Unregulated - The fungal-meningitis outbreak of 2012, which infected over 750 patients across the country and caused 60-plus deaths, became a turning...more
Years of Inspections, Reports, Letters from FDA Went Unheeded - MasterPharm Compounding Pharmacy in South Richmond Hill, N.Y., has recalled a “bad batch” of a drug called Finasteride Plus, known as FinPlus, that aids in...more
Litigation Update - On January 30, 2020, class action, consumer protection and pharmaceutical lawyers from around the country will be in federal court in Tampa, Florida to argue before a panel of federal judges whether...more
A last-minute deal between defendants McKesson, Cardinal Health, AmerisourceBergen, and Teva and plaintiffs’ attorneys means that multidistrict opioid epidemic litigation set to kick off in Ohio federal court today will not...more
Top Tidjane Thiam ally Pierre-Olivier Bouee, Credit Suisse’s COO, has resigned in the wake of an internal probe finding that he “ordered the surveillance of the bank’s former wealth-management chief, Iqbal Khan, without...more
The U.S. Food and Drug Administration (FDA) recently issued a final guidance document regarding the use, content, and circumstances for the issuance of public warnings and public notifications for firm-initiated or...more
Drug Manufacturing is Big Business - The Food and Drug Administration (FDA) has the responsibility to protect the health of U.S. consumers by ensuring food, drugs and medical devices are safe. The FDA also has a mission to...more
7 Deaths Associated With Medical Device - EpiPens exist to save lives or stave off severe allergic reactions to drugs, foods, insect bites and other causes of anaphylaxis. They are pocket-sized cylindrical devices that, in...more
Pharmacy compounding has been a very hot topic over the last 12 months. Whether it is news from Capitol Hill regarding possible legislation, regulation from the Food and Drug Administration (FDA) or action by a state board of...more