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The eyelash wars – U.S. district court in California grants partial summary judgment to Allergan, finding that Athena Cosmetic’s revitalash eyelash growth products are unapproved new drugs in violation of California law

August 20 2012 Allergan, Inc. (Allergan) is the manufacturer and distributor of the approved drugs Latisse® to promote eyelash growth and Lumigan® for glaucoma.

Fair Credit Reporting Act - adverse action notice requirements for users of credit scores to take effect July 21, 2011

May 9 2011 Among the many changes enacted as a part of last year's Dodd-Frank Wall Street Reform and Consumer Protection Act (Public Law 111-209) (Dodd- Frank) is an amendment to the Fair Credit Reporting Act (FCRA), 15 U.

The “independent contractor” truck driver, wage & hour laws, the Affordable Care Act, and safety regulations

July 16 2015 On The challenges that trucking companies face regarding truck drivers continue to expand. One vexing issue facing many companies: Can they continue…

Do the new medical device registration requirements really apply to me?

January 9 2013 FDA has changed certain medical device establishment registration and listing requirements in accordance with the Medical Device User Fee Amendments…

FDA publishes final rule on orphan-drug exclusivity

July 5 2013 On June 12, 2013, the Food and Drug Administration (FDA) issued a Final Rule amending the Orphan Drug Regulations (21 C.F.R. Part 316) issued to…

It's the Little Things: FDA Issues a Warning Letter for Improper Drug Listing

February 21 2022 In a nod to Alice Cooper's 2000 song, "It's the Little Things" (or, for literary fans, Robert Frost's quote, "It's the little details that are vital…

OIG’s First Advisory Opinion of 2022 Allows for Expansion of Discount Programs

February 14 2022 On January 19, 2022, the Department of Health and Human Services, Office of Inspector General ("OIG") released a favorable Advisory Opinion, OIG…

Freeze-Frame: FDA Issues an Untitled Letter for an Unlawful Instagram Post

January 28 2022 Does anyone remember the 1980's song, "Freeze-Frame" by The J. Geils Band? A New Year, a new Untitled Letter issued by the Food and Drug…

Tell Me, I’ve Got to Know: FDA Issues Draft Guidance on 506J Notifications for Medical Devices

January 26 2022 Bob Dylan sang, "Tell Me, I've Got to Know." In January 2022, the Food and Drug Administration said the same to the medical device industry when it…

You Cannot Do It Any Way You Want It: FDA Issues an Untitled Letter for an Incomplete Journey Forward

January 24 2022 Late last year, the Food and Drug Administration's Office of Prescription Drug Promotion issued an Untitled Letter to a drug company for unlawful…