Agency IQ

SEPTEMBER 15, 2023

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.

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FDA Law Blog: Biosimilars

SEPTEMBER 15, 2023

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

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Government Regulations FDA Drugs 64

Drug Channels

FEBRUARY 22, 2022

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, government regulations, and much more. Download a free report overview for more details.

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Pharmacy Specialty Pharmacies Biosimilars Licensing 96

FDA Law Blog: Biosimilars

MARCH 12, 2023

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

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FDA Law Blog: Biosimilars

MARCH 3, 2024

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.

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Laboratories Regulations FDA Government 64

FDA Law Blog: Biosimilars

MARCH 3, 2024

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.

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FDA Law Blog: Biosimilars

JANUARY 8, 2024

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.

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FDA Law Blog: Biosimilars

MARCH 4, 2024

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.

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Compliance FDA Regulations Government 59

Drug Discovery World

MARCH 29, 2023

She also does not believe that the problems with Europe’s medicines can be solved with regulation. From the industry perspective, that process has begun with the public commitment already in 2022 to file for pricing and reimbursement in all member states within two years of getting approval and documenting progress in a portal.

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FDA Law Blog: Biosimilars

JULY 2, 2024

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.

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FDA Regulations Government 52

The Pharma Data

APRIL 6, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

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Regulations Biosimilars Government Production 52

FDA Law Blog: Biosimilars

FEBRUARY 5, 2024

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.

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FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

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.

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Compliance FDA Government International 59

The Pharma Data

APRIL 8, 2021

persons outside the United States in reliance on Regulation S under the Securities Act. In member states of the European Economic Area, this announcement is directed only at persons who are “qualified investors” within the meaning of the Prospectus Regulation.

Regulations 52

Regulations Biosimilars Government Production 52

FDA Law Blog: Biosimilars

MARCH 24, 2024

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.

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Pharmacy Regulations Compliance Government 59

FDA Law Blog: Biosimilars

MAY 9, 2023

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.

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Government Regulations FDA Production 59

FDA Law Blog: Biosimilars

APRIL 24, 2024

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.

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FDA Government Regulations Production 59

FDA Law Blog: Biosimilars

JUNE 8, 2023

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.

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FDA Biosimilars Production Government 53

FDA Law Blog: Biosimilars

DECEMBER 7, 2023

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.

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Compliance FDA Regulations Government 52

FDA Law Blog: Biosimilars

JANUARY 4, 2024

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.

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Compliance FDA FDA Approval Regulations 52

FDA Law Blog: Biosimilars

NOVEMBER 6, 2023

The LMG awards are reflective of HPM’s excellence across several of our core life sciences practices, from controlled substances work to drug development, to Hatch-Waxman, to drug pricing, to medical device regulation. That combined depth and breadth of experience is why clients come to us.

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Science Government FDA Compliance 40

The Pharma Data

MAY 18, 2021

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.

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Biosimilars Government Production Pharmaceuticals 40

Drug Channels

FEBRUARY 21, 2023

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, government regulations, and much more.

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Pharmacy Specialty Pharmacies Licensing Licensing 97

FDA Law Blog: Biosimilars

DECEMBER 21, 2023

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.

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Compliance Regulations FDA Production 59

The Pharma Data

OCTOBER 27, 2020

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.

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Laboratories Biosimilars Government Pharmaceuticals 40

The Pharma Data

AUGUST 31, 2020

Portfolio of 15 generic and over-the-counter (OTC) medicines from Sandoz division will be sold at zero- profit to governments through Africa Medical Supplies Platform (AMSP) to 55 African and 15 Caricom eligible countries . The collaboration aims to help alleviate supply and logistical constraints in the African Union member states .

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Government Production Biosimilars Treatment 52

FDA Law Blog: Biosimilars

JULY 24, 2023

Jazz also argues that, notwithstanding the language that instructs FDA to promulgate regulations implementing the clinical superiority provisions at 21 U.S.C. 360cc(c), the statute does not permit FDA to promulgate regulations to use clinical superiority to break ODE.

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FDA Law Blog: Biosimilars

JUNE 16, 2023

For now, we will continue to monitor the law, its future implementing regulations, and any legal challenges as they develop.

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Drugs Biosimilars Production Treatment 45

FDA Law Blog: Biosimilars

JUNE 27, 2024

The Government alleged that Coconut Grove violated numerous federal and state controlled substance laws. The regulation requires that pharmacists “ensure that a reasonable effort is made to obtain” this information. 21 U.S.C. § 823(g)(1)(B), (D). at 50,376. “A 21 C.F.R. §§ 1306.04(a), 21 C.F.R. §§ 1306.04(a), a), 1306.06.

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Pharmacy Drugs Regulations Compliance 52

FDA Law Blog: Biosimilars

MARCH 9, 2023

Our firm has a great deal of experience in pleading with the Government not to prosecute clients that have discovered serious misconduct by employees (including management) and disclosed it to the Government voluntarily. But the Deputy AG’s speech was important for regulated industry because FDA doesn’t litigate its own cases.

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Compliance FDA Government Regulations 52

FDA Law Blog: Biosimilars

MAY 31, 2023

The government, while opposing the stay, stated it was willing to enter settlement discussions. Neither the CSA nor regulations promulgated by DEA provide any deadline for issuing a Final Order and Decision. According to that Order, Morris & Dickson had requested a stay of the Final Decision to renew settlement negotiations.

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Compliance Government Regulations Drugs 59

The Pharma Data

MARCH 5, 2021

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.

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The Pharma Data

MAY 15, 2023

In total, 4 out of 10 members of the new Sandoz Board of Directors will be female, resulting in an above average 40% female-to-male ratio for this important governance body. “I Find out more at [link] About Sandoz Sandoz, a Novartis division, is a global leader in generic pharmaceuticals and biosimilars.

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Science Doctors Government Compliance 40

The Pharma Data

SEPTEMBER 17, 2020

Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims.

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Therapies Production Government Biosimilars 52

FDA Law Blog: Biosimilars

OCTOBER 4, 2023

According to the court, the Constitution guarantees no right to conduct business with the government, so the consequences of that participation can be “conditioned by regulation” without being considered unconstitutional.

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Pharmaceuticals Government Regulations Drugs 59

The Pharma Data

JULY 27, 2021

Furthermore, our research, testing, pricing, marketing and other operations are subject to extensive regulation by domestic and foreign government regulatory authorities. Our business may be impacted by government investigations, litigation and product liability claims.

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Production Clinical Trials Government Disease 52

The Pharma Data

JANUARY 26, 2021

Through its three businesses – Pharmaceutical Services & Active Ingredients, Global Generics and Proprietary Products – Dr. Reddy’s offers a portfolio of products and services including APIs, custom pharmaceutical services, generics, biosimilars and differentiated formulations. Dr. Reddy’s operates in markets across the globe.

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