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…Report appear in its Appendices. As anyone who works in the compounding world knows, understanding positions of various states on issues such as sterile and non-sterile compounding, inspections, state licensing…
…associated with diseases in humans, including pneumonia, skin and tissue infections, pelvic inflammatory disease, and serious gastrointestinal infections in children. As a result, treatment of these infections in humans with…
…expires. According to Pfizer, “[t]o give effect to the Opinion and Final Order,” the court should, consistent with 35 U.S.C. § 271(e)(4)(A), amend its judgment to add that the effective…
…triggering purposes. Several years later, in Teva Pharm., USA, Inc. v. FDA, 398 F. Supp. 2d 176 (D.D.C. 2005), Teva challenged an FDA decision that a dismissal of a declaratory…
…products. If you have questions or need more information, contact: Jeffrey K. Shapiro, jshapiro@hpm.com, 202-737-9633 Jeffrey N. Gibbs, jgibbs@hpm.com, 202-737-4288 Jennifer D. Newberger, jnewberger@hpm.com, 202-737-4292 Allyson B. Mullen, amullen@hpm.com, 202-737-9639…
…recognized that compliance with postmarketing submission requirements poses unique difficulty for “real time” communications (e.g., blog posts, comments on a website, and twitter feeds), namely, the requirement that the firm…
…Delaware [Teva Pharmaceuticals USA Inc., Teva Pharmaceutical Industries Ltd., Teva Neuroscience, Inc., and Yeda Research and Development Co. Ltd. v. Mylan Pharmaceuticals Inc., Mylan Inc. and Natco Pharma Ltd., Civil…
…under the CPSA. Then, earlier this year, in April 2023, Gree USA, Inc., the U.S. subsidiary of the Chinese appliance company, was sentenced to pay a $500,000 criminal fine. The…
…on fat, saturated fat, trans fat, cholesterol, sodium, total carbohydrate, dietary fiber, sugars, and protein. Under proposed 21 C.F.R. § 101.8, certain vending machines would be required to disclose the…
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…appears to have gone largely unnoticed by industry, Facebook updated its Branded Content Policies in May 2021, and now prohibits the promotion of “drugs and drug-related products, including illegal, prescription,…
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…wishing to attend the meeting must register with FDA by November 5, 2007. Several other countries, including Australia, Canada, France, New Zealand, United Kingdom, Denmark, Germany, Italy, Netherlands, Sweden, and…