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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…

Private Wealth Newsletter - Three Reasons to Revisit Your Estate Plan in 2020

January 10 2020 The current estate planning environment, with low interest rates and high estate, gift, and generation-skipping transfer tax exemptions, provides…

Public Hearing on Proposed Georgia Telemedicine License Regulations Scheduled for January 9, 2020

January 8 2020 On December 9, 2019, the Georgia Composite Medical Board (the "Board") proposed rules that set forth the State's requirements for telemedicine…

Medicare Establishes Criteria to Allow Hospices to Accept Prescription Orders from Physician Assistants

January 8 2020 Exactly one year after the Bipartisan Budget Act of 2018 redefined the statutory definition of "attending physician" to allow physician assistants…

“A Perfect Storm”: OPDP Sends Warning Letter Regarding Print Advertisement for Drug to Treat Opioid Use Disorder—Failure to Disclose Serious Risks, Including Potential for Fatal Overdose

December 18 2019 On December 2, 2019, the Food and Drug Administration's Office of Prescription Drug Promotion (OPDP) sent a Warning Letter to the sponsor of a drug…

Is Your Cosmetic Product Really Natural? Congress Pushes for Legislation to Define the Term “Natural” for Cosmetics

December 18 2019 The use of the term "natural" on the labeling of FDA-regulated products has been the source of many lawsuits in recent years, and even the subject of…