Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Karin Moore has become its newest Director. Drawing on her years of experience as a former general counsel to leading trade associations, Karin is an industry expert and thought leader in the areas of …
Hyman, Phelps & McNamara, P.C. (“HP&M”) is pleased to announce that Richard Lewis has become its newest Senior Regulatory Device & Biologics Expert. Coming to us after more than 4 years at FDA, Richard worked in the Center for Biologics Evaluation and Research (CBER) and …
As more biosimilars are approved (we’re up to 26 now!), FDA has been rolling out guidance documents under the Biosimilars Action Plan (“BAP”). The most recent guidance has been long awaited. While the Hatch-Waxman Act explicitly provides that an applicant can seek approval for only …
Congress enacted several priority review voucher (“PRV”) programs in the past fifteen or so years with the goal of incentivizing drug companies to develop new drugs for diseases that ordinarily may not be attractive because the potential market is small or otherwise unlikely to produce …
Hyman, Phelps & McNamara, P.C. is pleased to publish the first FDA Law Alert of the new year. This is the fourth installment of our quarterly newsletter highlighting key postings from our nationally acclaimed FDA Law Blog. Please subscribe to the FDA Law Blog to …
Those familiar with the Hatch-Waxman Act and its various incentives to stimulate drug innovation know that New Chemical Entity (“NCE”) exclusivity is the holy grail of small molecule exclusivity. Though orphan drug may give a sponsor two more years of exclusivity than NCE, it only …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Sara Koblitz will be speaking in an upcoming Strafford live webinar, “Biologics and Biosimilars: FDA Initiatives and Guidance, Approvals and Exclusivity, Patent Prosecution, Litigation” scheduled for Thursday, February 13, 1:00pm-2:30pm EST. The panel will provide …
Lately, FDA has been subject to criticism on almost every front. A recent NY Times Op-Ed alleging political interference, the popular theory that FDA fueled the opioid crisis, and the quality and inspection concerns raised in the 2019 book Bottle of Lies are all emblematic …
On February 3rd, FDA announced several new actions as part of its Biosimilars Action Plan (BAP). If you recall, back in July 2018 when FDA first unveiled the BAP, four key elements were identified: improving efficiency of biosimilar and interchangeable product development; maximizing scientific and …
Only about 2 years after its last revision (which was only 5 months after its previous revision), FDA decided this week that MAPP 5240.3, Prioritization of Original ANDAs, Amendments, and Supplements, just wasn’t working. With too many ANDA submissions designated as priority, and thereby entitled …
The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp” – now in its 35th iteration – is scheduled to take place from March 24- 25, 2020 at DoubleTree By Hilton Metropolitan, New York, NY. The conference is billed as the premier event to provide folks with …
In a letter dated January 9, 2020, the Center for Science in the Public Interest (CSPI) asked FDA to take immediate enforcement action to prevent what CSPI argues are misleading and unauthorized implied “low sugar” and “reduced sugar” claims, such as “lightly sweetened” and “less …
Back in September 2019, California passed AB 824: Preserving Access to Affordable Drugs. That law sought to discourage “reverse-payment agreements” in which a brand manufacturer enters into a patent settlement agreement with a potential generic sponsor that involves a transfer of value from the brand …
Hyman, Phelps & McNamara, P.C. is pleased to announce that Serra Schlanger will present at this year’s Drug Pricing Transparency Congress, to be held in Philadelphia, PA on March 30-31, 2020. This conference gathers stakeholders to examine the evolving landscape of state drug price reporting …
Lystn, LLC (also doing business as Answers Pet Food; Lystn) is a pet food manufacturer of raw pet food. Lystn has been in a battle with FDA and the Colorado Department of Agriculture (CDA) since 2018 when CDA collected a sample of Lystn’s Straight Beef …
