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In areas like biologics, biosimilars, and interchangeable biosimilars, where emerging technologies meet regulatory complexities, this is perhaps a wise strategy. The top line from FDA for any cGMP-governed industry like these is always going to be that quality matters.
The CSA and regulations promulgated by DEA regulate the sale, import, and export of tableting machines the same as they regulate List I chemicals. The regulations also require detailed information about each transaction involving a tableting machine, including the date, name and address, quantity, method of transfer, etc.
Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept. The initiation of this study marks an important milestone in the development of our biosimilar aflibercept.
Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. By Jeffrey N. Gibbs & Steven J.
Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, governmentregulations, and much more. Download a free report overview for more details.
Sandoz strengthens pipeline expansion through partnership to develop and manufacture multiple biosimilars Sandoz, a global leader in off-patent (generic and biosimilar) medicines, today announced a multi-year partnership with Just – Evotec Biologics, the Seattle-based subsidiary of Evotec SE.
By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act).
But in addition to imposing civil penalties for alleged failure to comply with their obligations under the federal Controlled Substances Act and DEA regulations, the courts mandated how those registrants must handle controlled substances going forward. The government asserted additional allegations that are outside our scope.
With eight marketed biosimilar medicines globally and 15+ molecules in pipeline, Sandoz is investing in future of biosimilars for patients and healthcare systems. Holzkirchen, May 3, 2021 – Sandoz, a Novartis division, today announced progress in the late-stage clinical development program for its proposed biosimilar aflibercept.
The COVID-19 pandemic emergency forced federal regulators to take extraordinary measures to ensure that patients were permitted continued access to important medicines. These government measures included granting temporary exemptions from certain FDA and DEA legal requirements. Hyman, Phelps & McNamara, P.C.’s
By Riëtte van Laack — FDA regulates pet food similar to other animal foods. As anyone familiar with pet (and other animal) food regulation knows, many states require premarket label review and approval and registration of the manufacturer/distributor and/or product for a fee.
District Court for the District of Columbia (“DDC”) against FDA alleging that the Agency’s structure of NDA review is unconstitutional (by our count the 31st Vanda litigation against FDA or another government entity in the last five years, including appeals). In January 2024, the U.S. VANDA PHARMACEUTICALS, INC.
This proposed legislation should be of interest to any biotechnology companies that want to do business with the federal government in the future. The Act is intended to address national security concerns by prohibiting certain conduct by regulated industry. House of Representatives ( H.B. 7085 ) and Senate ( S.B.
Explainer: What a government shutdown would mean for the FDA (Updated) With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1. What is a government shut down? If none of the 12 bills are completed, then all government operations shut down.
On September 18-20, Informa Connect will hold its annual #MDRPSummit in Chicago (and via livestream) to discuss the complex, ever-evolving laws and regulations in the government pricing and price reporting space. A complete agenda is available here. Hyman, Phelps & McNamara, P.C.’s
Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, governmentregulations, and much more.
Mullen — FDA’s proposed rule to regulate laboratory developed tests (LDTs) as devices took one more step towards being finalized – and to a likely judicial showdown. This stands in marked contrast to FDA’s prior efforts to regulate LDTs (see posts here , here , and here ). By Jeffrey N. Gibbs & Allyson B.
Our feed saw a number of rosy forecasts for mergers and acquisitions in FDA-regulated industries. Assessing risks in regulated industry requires the appropriate depth and breadth of regulatory expertise. Deals in FDA regulated space are among the most complicated of any industry, and diligence adds cost.
Governors, state cannabis regulators, law enforcement groups and local governments weighed in, as did marijuana advocates and opponents, marijuana industry associations, Members of Congress, federal law enforcement groups, healthcare and human rights groups, unions and trade associations, and private individuals. 21 U.S.C. §
By Sara M Keup & Véronique Li, Senior Medical Device Regulation Expert — The American Conference Institute (“ACI”) held its 11th Annual Summit for Women Leaders in Life Sciences Law at the Seaport Hotel in Boston, Massachusetts on July 25th & 26th of last week. Women in Government and Judiciary Roundtable.
For first time, FDA releases OTC drug user fees prior to start of government fiscal year The FDA today unexpectedly unveiled certain user fees under its OTC Monograph User Fee Program (OMUFA), its nonprescription drug funding and performance mechanism. Industry wants its products reviewed quickly, efficiently and predictably.
Walsh, with over 26 years of experience in providing counsel to the pharmaceutical and medical device industries, will provide invaluable insights into global advertising and promotion regulations. Walsh’s unique perspectives on navigating the challenges and opportunities presented by advertising and promotion regulations worldwide.
Koblitz — You know a court decision is going to be worth reading when the judges compare FDA’s regulatory governance of flavored e-cigarettes to a Shakespearean gaslighting. Let’s just say, the smackdown—er, decision—eviscerates FDA’s approach to regulating flavored e-cigarettes. By David B. Clissold & Sara W.
In the interview, Khan spoke about the Commission’s efforts to regulate geolocation data trackers so that they don’t abuse their abilities. The news wasn’t all bad for the government, but FTC’s now has some decisions to make. But the judge also dealt a blow to the government, dismissing its suit against Kochava.
Walsh among an elite panel discussing “Around the World Hot Topics” – a session dedicated to exploring recent enforcement trends, regulator expectations, and best practices in white-collar crime law. This annual gathering, renowned for its influential speakers and dynamic networking opportunities, will see Ms. More notably, Ms.
Mullen — On January 18, 2024, the director of FDA’s Center for Devices and Radiological Health and the chief medical officer and acting director of CMS’ Center for Clinical Standards and Quality issued a joint press release supporting FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs).
When an ambiguous law or regulation is presented to a court, it is the court’s job to decide what it means, no matter how ambiguous or inartful the provision may be. In a recent trial, a jury verdict finding $43M in single damages has, according to the government , resulted in $490M in statutorily mandated liability.
Kirschenbaum — Last Friday, May 26, CMS published in the Federal Register an assortment of proposals to change the regulationsgoverning the Medicaid Drug Rebate Program. The CMS regulation (unlike the statute) would expansively define a “misclassification” to include, not only misclassifying the drug category (e.g.,
By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — On May 11, 2023, the U.S. The pandemic also deeply impacted how industry and the government conduct their operations. The pandemic also deeply impacted how industry and the government conduct their operations. However, not all changes are forever.
However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. The growing middle class and government initiatives to improve access to medicines have created an ecosystem for pharmaceutical companies seeking growth opportunities.
Field preemption applies when federal regulation occupies the regulated area so pervasively that it leaves no room for states to supplement it, even if the state law is consistent with the federal law. The court also noted that the practice of pharmacy is an area traditionally left to state regulation.
According to the dissent, where the government is the claimant, it concerns a public right. As the dissent points out, the federal government has operated for decades on the assumption that many disputes can be adjudicated by ALJs. We will be monitoring the effect of this decision on federal agencies and the regulated industry.
In line with plans announced with the Austrian government in July 2020, Sandoz confirms that in a first step it will proceed to invest more than €100 million to introduce new manufacturing technology for the production of oral amoxicillin, an active pharmaceutical ingredient (API) for its leading penicillin product. About Sandoz.
The meetings have presented a mix of views with some organizations meeting with OMB being in favor of FDA regulation and others being very much opposed.
HP&M has been helping clients navigate the challenges of state licensing regulations for drugs, biologics, medical devices, OTCs, 503B outsourcing facilities, 503A pharmacies, foods, dietary supplements, cannabis, and wholesalers/distributors for many years.
We’ve blogged on VSDs previously here and here , as the application of the VSD for FDA-regulated industry has been vexing. Panelists from CPB, FDA, and the Federal Trade Commission (FTC) all amplified the enduring government policy that they expect companies in the food and drug space have robust and legitimate compliance programs.
The American Conference Institute (“ACI”) will be hosting the go-to forum for critical updates on OTC regulation and enforcement, monograph reform, ACNU and advertising essentials… and FDA Law Blog readers can get a discount. Deb along with fellow panelists Kyle Y.
Commenting on his appointment, Parag Agarwal said, “Dr Reddy’s is driven by its purpose, high governance standards, a robust strategy and strong leadership. Saumen will continue to be associated with the Company as an Advisor. He will also help Parag to transition effectively. Dr. Reddy’s operates in markets across the globe.
When asked what excites FDLI the most about 2024 and the 75th anniversary, Simmon was quick to say, “FDLI has a front-row seat to the ever-changing and intriguing legal and regulatory developments impacting FDA-regulated products.
Claud — Among the tools that the government has to enforce the FDC Act is the injunctive power granted by Congress in 21 U.S.C. § For FDA regulated industry, injunctions arise most commonly as a result of negotiated consent decrees, but that does not mean that Starbucks is any less relevant. By JP Ellison & John W.M.
What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.
To sustain access, the Novartis generics and biosimilars division Sandoz became the first company to commit to keeping stable prices for a basket of essential medicines that may help in the treatment of COVID-19 and entered into a partnership with US-based Civica Rx to support stable supply of essential generic hospital medicines.
What We Expect the FDA to do in July 2023 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the month ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.
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