Document(s) published by this organization: 122
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|HHS Releases Final Rule Providing Individuals Greater Access Rights to Laboratory Records|
Robyn S. Shapiro, Jeremy Shapiro-Barr; Drinker Biddle & Reath LLP;
February 19, 2014, previously published on February 11, 2014On February 6, 2014, the Department of Health and Human Services (HHS) released a Final Rule that amends the Clinical Laboratory Improvement Amendments of 1988 (CLIA) and the Health Insurance Portability and Accountability Act of 1996 (HIPAA). The Final Rule provides that, by October 6, 2014,...
|Final FDA Guidance Clarifies Formatting and Content Requirements of “Dear Doctor” Letters without Requiring Behavior Tracking Evaluations|
Zoha Barkeshli, Michael C. Zogby; Drinker Biddle & Reath LLP;
February 13, 2014, previously published on February 10, 2014On January 23, 2014, the United States Food and Drug Administration (“FDA”) released a final guidance entitled Dear Health Care Provider Letters: Improving Communication of Important Safety Information, 75 Fed. Reg. 3827 (“Final Guidance”), in which the Agency provides...
|BIS Orders Company to Conduct External Audit in Settlement|
Joan Koenig, Mollie D. Sitkowski; Drinker Biddle & Reath LLP;
February 11, 2014, previously published on February 2, 2014On December 27, 2013, the Bureau of Industry and Security (BIS) in the U.S. Department of Commerce entered into a settlement agreement with Amplifier Research Corporation (AR). AR agreed to pay a $500,000 fine to settle charges that it committed 50 violations of the Export Administration...
|EPA Continues to Aggressively Target Distributors and Retailers Selling “Antimicrobial” Products|
Andrew P. Foster, Brian C. Foster, Pickard; Drinker Biddle & Reath LLP;
February 11, 2014, previously published on February 6, 2014With each passing year, retail markets seem to become more and more inundated with products described in one fashion or another as having “antimicrobial,” “antibacterial,” “fungistatic,” “germicidal” or similar properties. These so-called...
|Department of Commerce Expected to Revoke (Again) Antidumping Duty Orders on Ball Bearings from Japan and the UK|
Richard P. Ferrin, Douglas J. Heffner, William Randolph Rucker; Drinker Biddle & Reath LLP;
February 3, 2014, previously published on January 24, 2014The U.S. Department of Commerce (DOC) has notified the U.S. International Trade Commission (ITC) that it received no notice of intent from domestic ball bearings producers to participate in the sunset review the DOC initiated on January 2, 2014, regarding ball bearings and parts thereof from Japan...
|D.C. Circuit Vacates FCC’s Net Neutrality Rules|
Alisa R. Lahey, Camillie Landrón, Jennifer L. Oberhausen, Laura H. Phillips; Drinker Biddle & Reath LLP;
February 3, 2014, previously published on January 24, 2014In a much-anticipated opinion, on January 14, 2014, the Court of Appeals for the D.C. Circuit, in Verizon v. Federal Communications Commission, vacated the anti-discrimination and anti-blocking rules contained in the Federal Communications Commission’s (the “FCC” or...
|New York’s Proposed ERM and ORSA Requirements: A Uniform Approach?|
Drinker Biddle Reath LLP;
February 3, 2014, previously published on January 23, 2014New York’s recently proposed regulation on enterprise risk management (ERM) and own risk and solvency assessment (ORSA) incorporates many of the concepts adopted by the National Association of Insurance Commissioners (NAIC) and, so far, uniformly adopted by a number of states.
|FTC Announces Proposed Safe Harbor Certification Settlements|
Kenneth K. Dort; Drinker Biddle & Reath LLP;
February 3, 2014, previously published on January 29, 2014On Tuesday, January 21, 2014, the Federal Trade Commission (FTC) announced proposed settlements with 12 companies accused of falsely claiming that they had complied with the US-EU Safe Harbor Framework. These 12 companies are varied: they include three National Football League teams as well as a...
|CMS Adopts New Policy Permitting Release of Physician Medicare Billing Data to the Public|
Jesse A. Witten; Drinker Biddle & Reath LLP;
February 3, 2014, previously published on January 28, 2014On January 17, 2014, the Centers for Medicare & Medicaid Services (CMS) announced a reversal of long-standing agency policy, and will begin to release Medicare billing data of physicians in response to Freedom of Information Act (FOIA) requests, on a case-by-case basis. The policy will take...
|Lack of Ascertainability: A Strong Defense to Class Certification in Products Labeling Class Actions|
Richard E. Coe, Zoë K. Wilhelm; Drinker Biddle & Reath LLP;
January 17, 2014, previously published on January 13, 2014On Tuesday, January 7, a California court rejected a motion for class certification in Astiana v. Ben & Jerry’s Homemade, Inc., No. 10-4387, 2014 WL 60097 (N.D. Cal. Jan. 7, 2014), primarily on grounds that the proposed class was insufficiently ascertainable and common questions did not...