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…In the years since, there have been numerous legislative attempts to permit importation, but each attempt has failed (see, e.g., here). For its part, FDA has long opposed permitting individual…
…is completed. Product class-specific guidance documents must include criteria for determining biosimilarity, interchangeability, and immunogenicity (if available). In addition, companies may not submit a biogeneric application until the later of…
…Recognition Agreement” in place with the European Union and Cooperation Arrangements for drug products in place with Australia, Canada, Japan, Russia and Sweden. Under the Florida bill, drugs imported under…
As we have previously reported (see here, here, and here) four states (Vermont, Colorado, Florida, and Maine) have passed laws to establish drug importation programs. Reversing long-standing policy, the U.S….
…priority review voucher, the benefit is nothing to sneeze at. After all, companies pay hundreds of millions of dollars to obtain priority review stats. In fact, earlier this week, it…
…safe harbor warning. Proposition 65, California’s Safe Drinking Water and Toxic Enforcement Act of 1986, mandates that businesses that sell consumer products—including food, cosmetics, and OTC drugs—notify Californians about possible…
…2020 to June 10, 2020, from newer to older postings, under the “Documents” and “Comments” tabs, respectively. You just have to modify the dates in the URLs when you want…
…after considering comments, adopted the final rule, which will become effective on March 7, 2011. However, FDA is providing a grace-period of 1 year, stating that the Agency intends to…
…downloadable, and searchable online.” On March 11, 2011, this firm sent a letter to the FDA Chief Counsel, Ralph S. Tyler, calling on FDA to commit to posting on its…
…suspicious. Readers may remember that one year ago, on October 23, 2019, DEA announced the availability of the Suspicious Orders Report System (“SORS”) Online for reporting of suspicious orders, as…
…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…
…necessary. Comments are due by August 10, 2011.) Advertisers should also pay careful attention to how endorsements are provided in the world of online marketing, including blogs, Twitter, and Facebook. …
…comprehensive guide to the latest developments affecting ‘articles intended for cleansing, beautifying, promoting attractiveness, or altering the appearance’.” Among other topics, there will be a panel entitled: “Is it a…
…to waive into D.C. Bar). Compensation commensurate with experience. Excellent benefits package. Email resume to jwasserstein@hpm.com. For more information about the firm, see www.hpm.com. HP&M is an equal opportunity employer….
…a solution to companies that have discontinued ANDAs for drug products not currently marketed. A company called ANDA Repository, LLC (info@andarepository.com; and https://www.andarepository.com/) is offering what we can only characterize…