NIOSH Science Blog: Drugs

JULY 15, 2024

A Discussion Paper, Streamlining Regulatory Oversight of Respirators Used in Health Care Settings will Improve Worker Protection, was recently published in the National Academy of Medicine’s NAM Perspectives journal by respiratory experts outside of the federal government.

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Perficient: Drug Development

FEBRUARY 29, 2024

Providing this level of access control substantially increases the quality of governance while reducing the workload involved. Tagging can make these assets more seachable, manageable and governable. Geo-coding data with tags to comply with European regulations is also a possible target of opportunity.

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Drug Target Review

NOVEMBER 13, 2023

Regulating immunosuppression Beyond serving as a genetic on-off switch, Foxp3 controls greater genetic structural change within regulatory T cells, controlling chromatin architecture changes that subsequently guide the functional success of the peacekeeping immune cells.

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Perficient: Drug Development

OCTOBER 15, 2024

Lets talk about data governance in banking and financial services, one area I have loved working in and in various areas of it … where data isn’t just data, numbers aren’t just numbers … They’re sacred artifacts that need to be protected, documented, and, of course, regulated within an inch of their lives.

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FDA Law Blog: Biosimilars

FEBRUARY 7, 2024

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.

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FDA Law Blog: Biosimilars

JANUARY 28, 2024

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.

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Perficient: Drug Development

AUGUST 23, 2024

If you use Databricks , you probably know that Databricks Unity Catalog is the industry’s only unified and open governance solution for data and AI, built into the Databricks Data Intelligence Platform. Enhanced Query Performance Unity Catalog is well-known as a centralized metastore location in the context of governance.

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Common Sense for Drug Policy Blog

OCTOBER 1, 2024

New regulations governing methadone treatment for opioid use disorder go into effect in the US on October 2, 2024. As reported by the Associated Press on Sept. 20, 2024 ("US will let more people take methadone at home"):

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Agency IQ

NOVEMBER 10, 2023

The European Commission has proposed a regulation to revise the fees regulation governing the cost of compensating the European Medicines Agency (EMA) for its regulatory activities, with the aim of streamlining the fee structure and increasing fees in line with the cost of services and inflation.

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Drug Target Review

NOVEMBER 3, 2023

They identified ZNF800 as a key regulator of the differentiation of a specific gut cell type, the enteroendocrine cells. These hormones regulate digestive processes, like nutrient absorption, appetite, and glucose metabolism. This is like switching the ‘traffic lights’ on or off.”

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Agency IQ

MARCH 1, 2024

In this piece, AgencyIQ explains what a government shutdown would mean for FDA’s regulatory processes and for the industry it regulates. BY LAURA DIANGELO, MPH With Congress again debating the passage of appropriations legislation, the FDA is facing a potential shutdown of operations as of Midnight on March 1.

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biobide

SEPTEMBER 15, 2023

Given the potential harm that chemical pesticides may cause, they are naturally subject to strict regulation. These regulations have a major impact on the agricultural industry , in many cases limiting crop production and reducing income for farmers. In 2021, the UK government introduced new “Maximum Residue Levels”.

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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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Advarra

AUGUST 8, 2024

Artificial intelligence (AI) has taken the world by storm – and regulators are paying attention. These risks face fewer regulations but must meet certain standards to ensure ethical use. An example of limited and minimal risk systems include AI in benign gaming apps and language generators. a synthetic control arm)?

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FDA Law Blog: Biosimilars

MARCH 15, 2023

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).

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Perficient: Drug Development

AUGUST 19, 2024

Banks have silos, these silos have been created due to mergers, regulations, entities, risk types, chinese walls, data protection, land laws or sometimes just technological challenges over time. This ascertains completeness of the critical data elements definition and hence aid data governance strategy in a wholesome way.

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Drug Channels

MARCH 18, 2024

Informa Connect’s Life Sciences Pricing & Contracting USA May 21-23, 2024 | New Orleans Drug Channels readers save 10% with code 24DRCH10* Whether your daily focus is on Medicaid, Government Pricing, 340B, Drug Price Transparency, Commercial Contracting or Chargebacks , we have you covered!

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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

JUNE 12, 2023

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.

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FDA Law Blog: Biosimilars

DECEMBER 4, 2023

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.

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FDA Law Blog: Biosimilars

OCTOBER 1, 2024

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.

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Agency IQ

JULY 8, 2024

Supreme Court significantly expands time to file lawsuits over agency regulations The Supreme Court has issued its opinion in Corner Post v. 5 USC Sec 702 governs challenges to agency rules, with the statute permitting any person harmed by an agency’s action to pursue the agency in court over the specific harm.

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PPD

APRIL 30, 2024

31, 2022, the EU Clinical Trial Regulation (EU CTR) 536/2014 became applicable, heralding a new era for clinical trials in the European Union (EU). Transitioning to EU CTR requirements for existing studies Under the regulation, clinical trial applications submitted before Jan.

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Chemical Biology and Drug Design

SEPTEMBER 18, 2023

LRP1 regulates the clearance of Aβ in Alzheimer's disease. An inhibition of Aβ/RAGE-induced activation of MAPK and NOX governs the protection elicited by formononetin against inflammatory and oxidative stress-induced neuronal damage. RAGE activation promotes proinflammatory or proapoptotic cell responses.

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Policy Prescription

OCTOBER 22, 2024

Overall, the article addresses how to help people with private, government, or no health insurance. Additionally, federal law (separate from the FDA’s policy) states that regulators “should permit” individuals to import prescription drugs that otherwise might violate the law so long as the drugs do not pose an “unreasonable risk.”

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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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FDA Law Blog: Biosimilars

JULY 22, 2024

s John W.M. s John W.M.

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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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PPD

OCTOBER 17, 2024

There has also been an increase in government and regulatory support for CGT trials, in conjunction with an increase in investments for these products to get to market. The government has also enacted strict trade compliance policies that limit genetic materials, such as patient cells, leaving and entering China.

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Agency IQ

SEPTEMBER 1, 2023

EPA publishes amendments to PCB regulations The Environmental Protection Agency has finalized a suite of regulations related to polychlorinated biphenyls, including extraction, disposal, and cleanup regulations. PCB-specific regulations are codified in the Code of Federal Regulations. a closed system) uses of PCBs.

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Drug Channels

JULY 18, 2022

You'll return to the office having mastered complex regulatory guidelines to deliver compliant government pricing and reporting programs. Don’t miss the Medicaid Drug Rebate Program Summit coming up this fall in Chicago (or virtually).

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Agency IQ

JUNE 17, 2024

Swiss regulators align with EU on chemicals, biocides The Swiss Notification Authority for Chemicals has announced new adaptations are in the offing that will harmonize parts of the Swiss Chemicals and Biocidal Products ordinances with recent updates to corresponding EU legislation.

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Agency IQ

AUGUST 30, 2024

What we expect EU chemical regulators to do in September 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. A full list of chemical events is also scheduled for September, as regulators and regulatory affairs professionals return to work after the summer holidays.

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Agency IQ

MARCH 15, 2024

California publishes draft regulations for landmark plastic pollution reduction act CalRecycle has launched the formal rulemaking process for Senate Bill 54, which will implement a sweeping plan to reduce plastic waste in the state by 2032. However, a producer may also choose to apply for independent compliance with the requirements.

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Drug Patent Watch

FEBRUARY 26, 2025

However, the patentability of biologics is governed by specific laws and regulations, such as the Biologics Price Competition and Innovation Act (BPCIA). This requires a deep understanding of the science behind biologics, as well as the regulatory framework governing their development and approval.

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Agency IQ

AUGUST 2, 2024

What we expect EU chemical regulators to do in August 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Other consultations ending in August include two addressing potential candidates for substitution and exemption conditions under the Biocidal Products Regulation (BPR), including for the substance DBNPA.

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Agency IQ

AUGUST 25, 2023

Bavaria floats resolution in Bundesrat urging “PFAS regulation with a sense of proportion” Germany’s second largest state, Bavaria, has submitted a draft resolution for consideration in the upper house of parliament that urges German Chancellor Scholz’s government to “ensure a risk-based approach is maintained” in Brussels’ pursuit (..)

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