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…top blogs list is the second such list we’ve made in the past few months. In September, RNCentral.com named FDA Law Blog to their “100 Best Health Care Policy Blogs.”…
…list. Like all things Hatch-Waxman, it is quite complicated and takes a lot of time to figure out. Imagine, if you will, coming across a cache of 5,000-piece puzzles in…
…be desirable. Compensation is competitive and commensurate with experience. HPM is an equal opportunity employer. Please send your curriculum vitae, transcript, and a writing sample to Jeffrey N. Wasserstein (jnw@hpm.com). …
…and beverage companies, retailers, and ingredient suppliers to industry. Companies wishing to register for the seminar should contact Carolyn Werbler at answers@orcinternational.com. The seminar is scheduled for October 4 in…
By Kurt R. Karst – On September 22, 2010, Novartis Pharmaceuticals Corporation (“Novartis”) filed a Complaint in the U.S. District Court for the District of Columbia challenging FDA’s September 14th…
…Colorado Attorney General John W. Suthers, charged Dalbey, Marsha Kellogg, and others with misleading consumers about how much money they could make using the program. In the complaint, the FTC…
…You can access the conference brochure and sign up for the event here (or by emailing customerservice@americanconference.com or by calling 1-888-224-2480). We look forward to seeing you at the conference….
…trafficking issues and how to mitigate their risks in the businesses. Failure to comply, the law says, may subject the business to injunction actions brought by the state’s attorney general. …
…evaluation, participants will be asked to use the database and provide feedback. Participation can be in person in Washington, D.C. or online. Contact Kristina Schall at kristina.schall@opinionstrategies.com to sign up….
…trigger its 180-day exclusivity (which might not happen through commercial marketing because of the company’s manufacturing problems), and for which Ranbaxy qualified as a result of the company’s Paragraph IV…
…the decision below did serious damage to a federal statute of the highest importance. In concrete terms, the decision below will confer massive anti-competitive advantages on drug companies (both generic…
…AMP failed to comply with requirements in at least one quarter and more than three-fourths of manufacturers failed to comply with monthly AMP reporting requirements. See OIG, Drug Manufacturers’ Noncompliance…
…report can be found here. It confirms the general tenor of the 510(k) Working Group’s data, but provides greater detail and more sophisticated analysis. It is also more comprehensive: Boston…
…entities. Comments on both Notices are due by November 19. HRSA says it will consider the comments in formulating its proposed regulations. There will be another opportunity to comment on…
…notified of any agreement between a branded drug/biologic company and a generic/biosimilar company, or between two generic companies or two biosimilar companies, that relates to (1) “the manufacture, marketing, or…