The Premier Consulting Blog

MAY 4, 2023

billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1]. The new guidance provides detailed information to applicants and manufacturers regarding compliance with the requirements in 21 CFR Part 4 for ophthalmic drugs packaged with eye cups, eye droppers, or other dispensers. Regulatory Focus.

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DrugBank

NOVEMBER 7, 2023

EDMONTON, CANADA, November 1st, 2023— DrugBank today kicked off their role as a key distributor of the American Society for Health-System Pharmacists’s (ASHP) data. Discover ASHP Third-Party Packages in the Data Librar y ABOUT DRUGBANK DrugBank is the world’s first intelligent and comprehensive drug knowledge platform.

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Drug Discovery World

FEBRUARY 10, 2023

Scandinavia represents one of the most exciting but perhaps underrepresented markets for the discovery and development of pharmaceuticals. Sweden remains Scandinavia’s powerhouse market for pharmaceutical research and development. Sweden remains Scandinavia’s powerhouse market for pharmaceutical research and development.

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Agency IQ

SEPTEMBER 6, 2023

BY ALEXANDER GAFFNEY, MS, RAC SEP 1, 2023 6:21 PM CDT Regulatory background A warning letter is a significant occurrence for a company, and in particular if it follows an inspection of a company’s facility. What should the meeting request package include?

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FDA Law Blog: Biosimilars

JANUARY 3, 2024

Specifically, CVM ensures that animal drugs are safe and effective, properly made, and adequately labeled and packaged; food-producing animals only take drugs that would be safe for humans to consume; pet foods and additives are safe; and educates the public, monitors the market, and encourages development of new animal health products.

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Drug Discovery World

MARCH 29, 2023

On January 31 2023, an internally circulated version of the European Commission’s overhaul of the EU’s pharma legislation was leaked, and published by Politico 1. Hopefully, the final versions of the review, which will be published in the coming weeks, will contain additional analysis and data.”

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FDA Law Blog: Biosimilars

JANUARY 11, 2024

Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). This all sounds complicated, I know.

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Agency IQ

OCTOBER 6, 2023

BY RAYAN BHARGAVA, MSC | OCT 3, 2023 7:07 PM CDT PFAS background Commonly used in textiles, impregnation agents, paints, firefighting foams (AFFF), and many other applications, per- and polyfluoroalkyl substances (PFAS) have been linked with the incidence of cancer, liver damage, and fertility complications , among other health issues.

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Agency IQ

AUGUST 2, 2024

By Sebastian Godoy, MPH , Kirsten Messmer, PhD, RAC, Corey Jaseph, MS, RAC , Kari Oakes | Oct 25, 2023 5:20 PM CDT | Updated Jul 31, 2024 10:17 PM CDT What we expect to be talking about in August and September Based on our scanning, AgencyIQ expects that August will be another sleepy summer month for European regulators.

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Agency IQ

JULY 8, 2024

12/29/2023 FDORA, Section 3202 Rare Diseases: GAO to release a report to Congress assessing the policies, practices, and programs of the FDA with respect to the review of applications for approval of drugs and biologics intended to treat rare disease, with a focus on the effectiveness of FDA’s policies and challenges encountered by sponsors.

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Agency IQ

JANUARY 12, 2024

CDER’s latest novel drug approvals report shows how the pandemic is still affecting some drug approvals According to a report released this week describing CDER’s approval of 55 novel drugs in 2023, the agency failed to meet its goal dates under the Prescription Drug User Fee Act (PDUFA) Commitment Letter for 11% of applications – a record high.

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FDA Law Blog: Biosimilars

AUGUST 17, 2023

Tobolowsky — In January 2023, Vanda Pharmaceuticals, Inc. FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda) submitted two interesting and substantially similar citizen petitions (Docket Nos. 355(j)(2)(A)(v). .

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Practical Cheminformatics

JANUARY 2, 2024

Here’s the first part of my review of some interesting machine learning (ML) papers I read in 2023. Review articles 2023 was a bit of a mixed bag for AI in drug discovery. In 2023, these methods underwent additional scrutiny, and it turned out that they weren’t quite as good as originally reported. Are the Comparisons Fair?

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Agency IQ

JANUARY 19, 2024

Commission unveils “one substance, one assessment” reform package The Commission has long aspired to realize its one substance, one assessment concept in the EU’s chemical regulatory regime. This proposal is long overdue, as it was initially slated for the first quarter of 2023. [ The proposed regulation is divided into 9 chapters.

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Agency IQ

NOVEMBER 3, 2023

BY KIRSTEN MESSMER, PHD, RAC | OCT 27, 2023 8:03 PM CDT Background on E.U. The Pharmaceutical Group of the European Union (PGEU) conducted a survey finding shortages worsened in 2022 compared to 2021, with most European countries reporting worsening. healthcare systems for years. [See wide level.

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Agency IQ

MAY 31, 2024

BY SEBASTIAN GODOY, MPH , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES , CHELSEY MCINTYRE, PHARMD | OCT 25, 2023 5:20 PM CDT | UPDATED MAY 30, 2024 12:16 PM CDT What we expect to be talking about in June Regulators of all sizes – from the EMA to national competent authorities – will be busy with meetings in June.

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Agency IQ

MAY 3, 2024

12/29/2023 FDORA, Section 2512 Shortages : FDA must review its policies related to drug or biologic expiration dates and issue draft guidance or revise existing guidance on stability testing data in drug and biological product submissions.

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Agency IQ

AUGUST 2, 2024

Letter Program Tag Commitment Due Date MDUFA International Harmonization Commencing with FY 2024, publish an annual assessment of the international harmonization activities described the strategic plan due by the end of FY 2023. use of RWE, registries) for capturing post-approval safety and efficacy data for cell and gene therapy products.

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Agency IQ

JUNE 26, 2023

BY AMANDA CONTI, ALEXANDER GAFFNEY, MS, RAC JUN 21, 2023 6:53 PM CDT Background: legislative efforts to bolster rare disease drug development Defining a “rare disease:” In the U.S., a disease or condition is defined as rare by the Orphan Drug Act (ODA) if it affects fewer than 200,000 people. Recently, U.S. In particular, Sec. regulators.

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Agency IQ

MAY 17, 2024

Over the course of an afternoon on May 9, 2023 speakers from FDA’s Center for Drugs Evaluation and Research (CDER) described when pre-submission meeting requests are appropriate, what the expectations are for applicants prior to and during these meetings; and how the FDA has redesigned PSUB meetings under GDUFA III.

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Drug Target Review

FEBRUARY 1, 2024

Two recent transactions both occurring in Q4 2023 prove this point. The organizing principle is the data package. We were able to license a molecule from a multi-national pharmaceutical company. Every constituency in our ecosystem is rooting for success, and when it happens you see folks lean in; strategic and investors alike.

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Drug Discovery World

OCTOBER 3, 2023

The assessment, commissioned by the European Federation of Pharmaceutical Industries and Associations (EFPIA), was conducted by Dolon, a strategic consultancy specialising in rare diseases. Plans to overhaul the EU regulation on rare disease therapies risk undermining two decades of progress, a new report claims.

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Drug Discovery World

FEBRUARY 22, 2023

Gary Connors , Partner at business consulting company Oliver Wight EAME looks at some of the most important factors that will affect the pharmaceutical industry going forward. We advise all our clients to make assumptions and think about scenarios that could affect their business at least five years in advance.

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Agency IQ

DECEMBER 1, 2023

What We Expect the FDA to do in December 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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Agency IQ

OCTOBER 27, 2023

What We Expect the FDA to do in November 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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Agency IQ

JULY 12, 2024

In May 2023, a non-paper drafted by the Belgian government, obtained by POLITICO Pro EU, called attention to the continuing issue of medicine supply shortages. In October 2024, the European Commission published a communication putting forth a package of reforms to address medicines shortages. points of disruption).

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The Premier Consulting Blog

APRIL 27, 2023

Then, in 1997, the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) formed the ICH M8 Expert Working Group/Implementation Working Group (EWG/IWG). As of April 2023, the FDA is overseeing its eCTD v4.0 Implementation Package v1.5 Implementation Package v1.5

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Agency IQ

APRIL 12, 2024

Potency assays for cell and gene therapies: The newest guidance At the very end of 2023, the FDA released a draft guidance on establishing CGT product potency to replace its previous 2011 version. FDA-2023-D-4299: Potency Assurance for Cellular and Gene Therapy Products

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Drug Discovery World

AUGUST 10, 2023

In this article, Amplexor asks some of the company’s closest industry partners and BE THE EXPERT event speakers for their views on the biggest developments in the Life Sciences Regulatory sphere over the last 12 months – and explore some of the most prominent themes and priorities seen throughout 2023.

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Agency IQ

OCTOBER 6, 2023

FDA fiscal year in review: New drug approvals in the wake of the pandemic and legislative reforms AgencyIQ analyzed CDER’s novel drug approvals in Fiscal Year 2023, identifying a recovery in approval numbers as the agency resumes a new normal following the pandemic. CDER approved 51 new molecular entities in FY 2023.

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Agency IQ

NOVEMBER 27, 2023

Many posted comments came from professional pharmacy organizations, trade groups like the Pharmaceutical Research and Manufacturers of America (PhRMA) , and pharmaceutical companies, such a Eli Lilly , Novo Nordisk and Merck.

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Agency IQ

AUGUST 4, 2023

BY KIRSTEN MESSMER, PHD, RAC AUG 2, 2023 12:18 AM CDT Background The U.K.’s pharmaceutical law ceased to apply to the U.K. s Medicines and Healthcare products Regulatory Agency (MHRA) has been releasing guidance for the pharmaceutical and medical device industry to aid product development and approval after the separation.

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Agency IQ

MAY 3, 2024

BY CHELSEY MCINTYRE, PHARMD , KIRSTEN MESSMER, PHD, RAC , COREY JASEPH, MS, RAC , KARI OAKES , SEBASTIAN GODOY, MPH | OCT 25, 2023 5:20 PM CDT | UPDATED APR 30, 2024 12:57 PM CDT What we expect to be talking about in May: Regulators, especially from the EMA and national competent authorities, will be busy with lots of meetings in May.

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Agency IQ

MARCH 15, 2024

California implements a variety of extended producer responsibility (EPR), programs, including programs to address paint, carpet, mattress, pharmaceutical and battery waste. Cutting waste: By 2032, SB 54 requires that the state cut the use of single-use packaging and food service ware by 25%.

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Agency IQ

NOVEMBER 3, 2023

BY CHELSEY MCINTYRE, PHARMD | OCT 30, 2023 10:57 PM CDT Background: What are microbiome-based therapies? The prebiotic may either feed the probiotic that it is packaged with, or it may feed another beneficial microbe that is intended to complement the activity of the probiotic. What is the microbiome itself?

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Drug Discovery World

JANUARY 23, 2024

2023 was a momentous year of growth and development for the company, with the launch of a new brand identity, a state-of-the-art facility expansion, and exciting new scientific partnerships. Game-changing results across a range of projects 2023 saw a number of new partners adopt Sphere Fluidics’ single cell analysis systems.

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Practical Cheminformatics

JANUARY 8, 2024

Picking up where we left off in Part I , this post covers several other ML in drug discovery topics that interested me in 2023. Large Language Models The emergence of GPT-4 and ChatGPT brought considerable attention to large language models (LLMs) in 2023. Papers published in 2023 showed how robust the method is. Other Stuff 4.

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