The Premier Consulting Blog

APRIL 13, 2025

In 2019, we published a detailed peer-review article outlining this process based on our long history of leveraging existing animal and human data to streamline drug development programs and reduce or eliminate animal testing under the 505(b)(2) pathway.[ For questions on NAMs and the impact to your program , contact us. 3] Salminen et al.

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KIF1A

OCTOBER 21, 2023

But what regulates the delivery of materials at these early stages? In this week’s article, researchers investigated KIF1A’s role in the delivery of synaptic building blocks, and its regulation by the lipid (fat molecule) PI(3,5)P2. From Gabrych et al.

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Agency IQ

SEPTEMBER 15, 2023

PFAS regulation in California (late 2023 edition) California consistently maintains its status as both one of the most important economies in the world as well as one of the most regulated states in the United States. The division revised those levels in August 2019 to 6.5 ppt for PFOS and 5.1

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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

MAY 31, 2024

What we expect EU chemical regulators to do in June 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Another consultation is closing this month on a draft implementing regulation that is amending the label format for fluorinated greenhouse gases (F-gases) under the new F-gas Regulation (EU) 2024/573.

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Agency IQ

DECEMBER 1, 2023

What we expect EU regulators to do in December 2023 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. Highlights of chemical regulatory activities Consultations open under the REACH and CLP regulations are coming to an end in December. Events happening next month include two ECHA meetings (i.e.,

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Drug Target Review

SEPTEMBER 25, 2024

BRAF and downstream mitogen-activated extracellular signal-regulated kinase (MEK) inhibitors are combined to treat BRAF-mutated melanoma, for example. Inhibiting KDM5A, a regulator of cell proliferation, poses another interesting approach. 2019 Dec 13 [cited 2024 Sep 4];122(4):465–72. Nature Reviews Drug Discovery [Internet].

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Policy Prescription

AUGUST 25, 2022

This past June, during a debate in the Senate Health, Education, Labor and Pensions (HELP) Committee, Senator Richard Burr (R-NC), the committee’s Ranking Member, demonstrated that he does not understand very important developments in our nation’s approach to drug regulation and safety. It was almost as if Sen. Those are facts.

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Agency IQ

MAY 28, 2024

Updates to TSCA new chemicals regulations hit OIRA for review The Office of Information and Regulatory Affairs has begun review of a final rule that will change how the EPA handles new chemical reviews under the Toxic Substances Control Act (TSCA). TSCA itself has numerous subsections focused on different aspects of chemical regulation.

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Agency IQ

MAY 3, 2024

What we expect EU chemical regulators to do in May 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. On May 29-30, the agency will host ECHA IT Days , a two-day conference held in Helsinki, Finland dedicated to all things related to information technology and chemical regulations.

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Agency IQ

OCTOBER 27, 2023

What we expect EU regulators to do in November 2023 Welcome to AgencyIQ’s roundup of upcoming regulatory activities in the EU chemicals sector. Regulation on detergents and surfactants The expert working group on detergents is scheduled to hold a meeting on November 17.

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Agency IQ

JANUARY 4, 2024

What we expect EU regulators to do in January 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA plays a central role in this reassignment of duties, and it would make sense for the basic regulation to be introduced at the same time as these other proposals.

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Agency IQ

FEBRUARY 2, 2024

What we expect EU regulators to do in February 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. BY SCOTT STEPHENS, MPA | JAN 26, 2024 10:22 PM CST Highlights of upcoming chemical regulatory activities Consultations under the REACH and CLP regulations are coming to an end in February.

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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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Drug Target Review

OCTOBER 12, 2023

Although non-coding variants have been increasingly appreciated for their essential role in controlling gene expression across cell types and tissues, scientists find it difficult to match them to the genes they regulate, the effects on AD-related functions and thus the individual risk of contracting AD. Frontiers [Internet].

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Agency IQ

MARCH 1, 2024

What we expect EU regulators to do in March 2024 Welcome to AgencyIQ’s monthly roundup of EU chemical sector activities. ECHA consultations under the CLP Regulation closing in March CLP: Harmonized classification and labeling (CLH) Consultations on classification and labeling harmonization (CLH) are open for 60 days.

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FDA Law Blog: Biosimilars

SEPTEMBER 11, 2023

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — On September 6, 2023, FDA announced its latest efforts to modernize the 510(k) process, outlining FDA’s latest improvements to strengthen the 510(k) Program and announcing release of three draft guidance documents.

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Agency IQ

NOVEMBER 10, 2023

The adoption of a “fees payable” regulation, Council Regulation (EC) No 297/95 , permitted (and continues to permit) the regulator to assess fees for many of the services it provides to medicines developers. There are other fee-related regulations as well. See AgencyIQ’s analysis of the fees explanatory note correction.]

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Agency IQ

JULY 21, 2023

New EPA regulations to sweep up lead levels in many structures The Environmental Protection Agency has announced new dust-lead hazard standards and clearance levels, which regulate levels of lead dust on floors and windowsills. New proposed EPA regulations On July 12, 2023, the EPA announced that it was reducing both the DLHS and DLCL.

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FDA Law Blog: Biosimilars

NOVEMBER 1, 2023

Lenz, Principal Medical Device Regulation Expert & Sophia R. Gibbs — For more than three decades, FDA has claimed that the Federal Food, Drug & Cosmetic (FD&C Act) gives the agency legal authority to regulate laboratory developed tests (LDTs) as medical devices (see our prior post here ). Gaulkin & Jeffrey N.

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Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

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Common Sense for Drug Policy Blog

OCTOBER 4, 2024

Many states have banned or are testing for vitamin E acetate because of the 2019 outbreak of e-cigarette or vaping product–associated lung injury (EVALI) (Schauer, 2021). Consumer Protection and Vape Products "The 2021 review of cannabis policy found that states also have limits on ingredients that can be contained in cannabis products.

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Common Sense for Drug Policy Blog

JUNE 24, 2024

The last decade has been characterized by a remarkable dynamism of change in the illicit drug market with the constant introduction of new substances synthesized to circumvent regulation. A review of synthetic cathinones emerging in recent years (2019–2022). This phenomenon has also applied to synthetic cathinones [ 4 , 5 , 6 ].

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DrugBank

OCTOBER 4, 2024

However, ensuring that these structures comply with applicable tax laws and regulations is essential to avoid potential legal and reputational risks. Recent changes in drug approval processes, intellectual property laws, and pricing regulations have introduced both opportunities and challenges for dealmakers.

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Drug Target Review

SEPTEMBER 26, 2023

Ther Innov Regul Sci. 2019 Mar 1;55:93–100. 2019 Nov 1;8(6):784–8. Regul Toxicol Pharmacol RTP. 2019 Jun;78:130–41. Strauss DG, Gintant G, Li Z, Wu W, Blinova K, Vicente J, et al. 2018;53(4):519–25. Colatsky T, Fermini B, Gintant G, Pierson JB, Sager P, Sekino Y, et al. Drug Discov Today. 2009 Sep;14(17–18):876–84.

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Agency IQ

APRIL 12, 2024

Landscape analysis: A look at the regulation of decentralized trials and what’s coming soon In the past few years, regulators and researchers have shown increased interest in leveraging decentralized trial methods – especially following the pandemic. In early 2023, AgencyIQ conducted a landscape analysis of DCT policy in the U.S.

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FDA Law Blog: Biosimilars

MAY 13, 2024

Gibbs & Ana Loloei & Véronique Li, Senior Medical Device Regulation Expert — FDA has long touted the use of real-world evidence ( RWE ). By Jeffrey N. During this period the estimated total number of such submissions was approximately 26,121.

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The Pharma Data

DECEMBER 12, 2020

Alexion achieved impressive revenue growth over the last few years, with revenues of $5.0bn in 2019 (21% year-on-year growth). During 2019, Alexion generated a total revenue of $5bn and profit before tax of $2.2bn. Any failure to comply with this restriction may constitute a violation of such laws or regulations.

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FDA Law Blog: Biosimilars

MAY 31, 2023

On May 24, 2019, Morris & Dickson paid a $22 million civil penalty related to the failure to report suspicious orders and ignoring certain red flags in the distribution of controlled substances. Neither the CSA nor regulations promulgated by DEA provide any deadline for issuing a Final Order and Decision.

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The Pharma Data

DECEMBER 10, 2020

The Company’s ordinary shares are listed on the regulated market of Euronext Paris under the ticker symbol “NANO.”. Any stabilization action or over-allotment shall be carried out in accordance with all applicable rules and regulations and may be undertaken on the regulated market of Euronext in Paris and on the Nasdaq Global Select Market.

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Agency IQ

OCTOBER 12, 2023

While this development, on its own, is noteworthy, the judiciary rationale behind the ruling will impact wider EU trends and serve as precedent for future chemical regulation. These statements emboldened member states to vote in favor of draft implementing acts denying renewal for both active substances in December 2019.

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The Pharma Data

JANUARY 19, 2021

This announcement is not a prospectus within the meaning of the Regulation (EU) n°2017/1129 of 14 June 2017 as amended by Regulations Delegated (EU) n°2019/980 of 14 March 2019 and n°2019/979 of 14 March 2019. This press release is provided “as is” without any representation or warranty of any kind.

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H1 Blog

NOVEMBER 15, 2023

But in today’s highly regulated environment, it is more important than ever to make sure that HCP engagement plans are compliant with anti-kickback laws. However, with strict regulations surrounding interactions between industry and healthcare professionals, compliance must be at the forefront of any KOL engagement plan.

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Advarra

DECEMBER 15, 2022

Policies and Regulations Affecting Single IRB Review. Health and Human Services (HHS) regulations as much as practicable, which includes sIRB requirements. This requirement entered the regulations as part of a broader update in 2017, commonly referred to as the Revised Common Rule. Nonexempt human subjects research.

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Advarra

MARCH 5, 2024

While the regulations governing clinical research refer to “noncompliance” several times, the term is not actually defined in the regulations. Note: This article was originally published December 4, 2019, and has been updated to include new and clarifying information.

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The Pharma Data

JANUARY 19, 2021

The authors suggest natural tracr-L regulates autoimmunity. And in 2019, Caribou co-founder and CRISPR pioneer Jennifer Doudna co-authored a Nature Communications paper describing a system of activating and deactivating single guide RNAs using small-molecule ligands.

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Perficient: Drug Development

AUGUST 16, 2023

In 2019, it expanded by buying its fourth branch from a competitor. Bank Closed By Regulators Almost all bank closures happen on a Friday so that regulators can work all weekend to reopen the bank on Monday. billion in deposits), the failure still poses lessons for bank executives.

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