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…with opioid use disorder. Detoxification on its own, without medications for opioid use disorder, is not recommended for opioid use disorder because of increased risks for resuming drug use, overdose,…
On April 27, 2018, Petitioners Breckenridge Pharmaceutical, Inc. and Nexgen Pharma, Inc. filed a Petition for Review in the United States Court of Appeals for the District of Columbia Circuit….
…put forward proposals to significantly reduce drug prices by August 24. On Sunday, September 13, not having elicited the desired reaction from manufacturers, Trump issued the threatened Executive Order on…
…an individual, by a partner if the registrant is a partnership, or by an officer if the registrant is a corporation, corporate division, association, trust, or other entity, any corporate…
…the FTC Staff’s cross appeal. As a result, the final order is broader than the order issued by the ALJ in 2012. Specifically, the Commission concluded that: 36 (compared to…
…Massachusetts Department of Public Health (“DPH”) and its Commissioner, Cheryl Bartlett, RN, to take several actions to combat opioid overdose, including granting DPH “emergency powers” to, among other things, ban…
…submitted to FDA and Health Canada within 6 months of acceptance of the pilot program: For FDA, specify if it is a 510(k), De Novo, or pre-market approval (PMA) original,…
…the OTC monograph reform. Deb along with fellow panelists Kyle Y. Faget, Partner, Foley & Lardner LLP and Amy Replogle, Director, Rx-to-OTC Switch, Bayer will present a must-attend panel focusing…
…of the original tentative final order, and thirty-six years after the initial proposed order, the FDA has yet to finalize the Monograph. In the meantime, [OTC] antimicrobial drug products containing…
On Friday, July 24, Donald Trump signed three Executive Orders addressing the high prices of prescription drugs, and threatened to sign a fourth if drug manufacturers do not put forward…
…November 4, 2014, three related entities – Elliott Associates, L.P., Elliott International, L.P., and Knollwood Investments, L.P. (collectively “Elliott”) – with investment interests in COLCRYS filed a separate Complaint against…
…to hold hearings, with medical and public health experts testifying, to come to a decision about the tradeoff between lowering the sensitivity threshold versus enabling widespread availability of OTC rapid…
As we previously reported, in March, as part of the CARES Act, OTC monograph reform was signed into law. This law amended the FDC Act to include, among other things,…
…non-steroidal anti-inflammatory drugs (“NSAIDs”), like aspirin, ibuprofen, naproxen, and ketoprofen. In addition, the final rule requires that certain information, such as ingredient names, be prominently displayed on principal display panels…
On April 12, 2007, the Association of American Physicians & Surgeons (“AAPS”), Concerned Women for America, Family Research Council, and Safe Drugs For Women filed a complaint in the U.S….