Mondaq USA: Food, Drugs, Healthcare, Life Sciences
Reed Smith
You'll have to excuse us a bit today.
Arnold & Porter
While the Clinical Trials Regulation (EU No. 536/2014) (the Regulation) was adopted in April 2014, the Regulation does not come into operation until 6 months ...
Ropes & Gray LLP
The changes to the guidance documents are extensive, but generally provide additional flexibility for manufacturers to convey certain types of product information.
Morgan Lewis
The documents issued by the US Food and Drug Administration on shared system risk evaluation and mitigation strategies signal the FDA's willingness to grant waivers from the shared program requirement, but that may complicate matters for the companies trying to negotiate them and the healthcare providers trying to navigate them.
Reed Smith
The MDL court in the Testosterone Replacement Therapy litigation recently entered summary judgment in favor of a non-US manufacturer that did not distribute in the US, along with its US subsidiary.
Arnold & Porter
On June 12, 2018, the US FDA issued revised, final versions of two guidance documents, "Drug and Device Manufacturer Communications with Payors, Formulary Committees and Similar Entities—Questions and Answers"...
Smith Gambrell & Russell LLP
President Trump's administration continues in its mission to dismantle the Affordable Care Act (ACA). While attempts to repeal the ACA through legislation have not succeeded ...
Foley & Lardner
Those who follow hospital and health system M&A activity know that the market has been "frothy."
Reed Smith
Nothing else works very well at treating Alzheimer's disease.
Troutman Sanders LLP
Legislators in New York are looking to pass a bill that would ban the sale of flavored e-liquid tobacco products.
Cooley LLP
The FDA further stated that it the "ultimate goal is to help facilitate a market that is more competitive" and benefits patients.
Day Pitney LLP
FDA Releases Long-Awaited Off-Label Guidance.
Ropes & Gray LLP
FDA Commissioner Scott Gottlieb has vowed to take steps to speed the review and approval of generic drugs as part of his overall priority to address concerns about drug prices.
Duane Morris LLP
This scheme, called the FDA's product jurisdiction, has remained largely unchanged since 1991.
Sheppard Mullin Richter & Hampton
On Wednesday, June 6, 2018, President Trump signed into law the "John S. McCain III, Daniel K. Akaka, and Samuel R. Johnson VA Maintaining Internal Systems and Strengthening Integrated Networks Act"...
Shearman & Sterling LLP
On June 4, 2018, Judge Yvonne Gonzalez Rogers of the United States District Court for the Northern District of California dismissed with prejudice a class action alleging that Dynavax...
Cooley LLP
Today, the U.S. Food and Drug Administration (FDA) released guidance titled, Patient-Focused Drug Development: Collecting Comprehensive and Representative Input (Guidance 1),...
Finnegan, Henderson, Farabow, Garrett & Dunner, LLP
The draft guidance identifies the five types of formal meetings that occur between sponsors and FDA staff to discuss a biosimilar or interchangeable product and describes important procedures for each meeting:
Pryor Cashman LLP
In partnership with LifeSci NYC, Pryor Cashman will host a two-day financial planning event for emergent life sciences ventures pursuing professional investment.
Holland & Knight
Imagine for a moment that you own a world-class bakery and make the best pies around. What would your reaction be if state law prohibited you from selling your plies ...
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Foley Hoag LLP
Earlier this year, the Department of Justice, Civil Division, issued two policy memos that will directly affect its civil enforcement priorities, particularly with regard to healthcare and life sciences companies.
Shearman & Sterling LLP
This past year has seen renewed challenges to reverse payment settlement agreements in the pharmaceutical industry.
Singh & Associates
An experimental drug derived from cannabis is well poised to become the first of its kind drug to win approval from the United States Food and Drug Administration (USFDA).
Morrison Mahoney LLP
When the internet started to gain widespread commercial use in the early 1990s, few could have predicted the massive shift that it would have on our lives. Its power has been harnessed...
Wilson Elser Moskowitz Edelman & Dicker LLP
Also named is SC Laboratories Inc., the logo of which appears on the vape cartigage product's packaging.
McDermott Will & Emery
On April 30, 2018, the U.S. District Court for the District of Massachusetts dismissed the last remaining state FCA claims against long-term care pharmacy provider PharMerica, Inc. on the grounds that neither relator...
Holland & Knight
On April 30, 2018, the U.S. Department of Health and Human Services (HHS) Office of Inspector General (OIG) issued a favorable Advisory Opinion No. 18-02 regarding the provision of sample ostomy products...
Seyfarth Shaw LLP
California's AB 2069, a bill to require employers to accommodate medical cannabis users, recently failed to advance past committee.
Davis & Gilbert
The U.S. Food and Drug Administration (FDA) and class action bar are continuing to pursue enforcement and litigation against food and dietary supplement manufacturers who make drug claims ...
Akin Gump Strauss Hauer & Feld LLP
Washington saw a flurry of bipartisan activity over the last few weeks. Most notably, Republican and Democratic negotiators reached a long-awaited deal on sequestration budget caps.
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