Agency IQ

MAY 17, 2024

BY RACHEL COE, MSC | MAY 10, 2024 5:19 PM CDT Generic Drug User Fee Amendments (GDUFA) III The Generic Drug User Fee Agreement (GDUFA) was first passed in 2012 as part of the FDA Safety and Innovation Act (FDASIA) to bolster FDA’s resources for the review and approval of generic drugs. What to expect on the day of the meeting?

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Agency IQ

JUNE 7, 2024

The regulations increase focus on post-market requirements and expect continuous and instantaneous updates to all reports and documents when either the product or the benefit-risk ratio changes. These comprise the MDS series (MDS 7000, 7200). See Table 4 for a list of the codes that have the highest Notified Body designations.

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Agency IQ

NOVEMBER 27, 2023

In some cases, the groups requested ad-by-ad reviews, potentially via collaboration with independent market research organizations. The results of this study were posted to the docket for the proposed rule in February 2012. submitted the results of their own market research study on a fictitious drug.

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Agency IQ

AUGUST 4, 2023

This past week, the MHRA provided guidance on labeling of medicines destined for Northern Ireland, with provisions to ensure that medicines only move into Northern Ireland market and don’t re-enter E.U. The European centralized marketing authorization procedure is no longer a valid medicines approval pathway for the U.K. member states.

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Practical Cheminformatics

DECEMBER 4, 2022

Finally, we will look at a simple application of the method and explore the ring systems in marketed drugs. In addition, the core code for extracting ring systems from molecules has been incorporated into the latest version of my pip installable useful_rdkit_utils package. Mühlbacher, J., Schuffenhauer, A., & & Selzer, P.

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Agency IQ

MAY 3, 2024

The pharma reform package remains in E.U. In the interim, the European Council will continue to discuss the package, and stakeholders may gain some insight into the Council’s thinking near the end of May. leaders’ eyesight as the Parliament winds down ahead of its June elections. On April 10, the E.U. On April 10, the E.U.

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The Pharma Data

AUGUST 3, 2021

Selling, General & Administrative (SG&A) expenses increased 7% driven by marketed product support due to increased customer engagement in response to the pandemic recovery and investment in new product launches. Tax Court to contest notices of deficiencies received from the IRS during the quarter for 2010, 2011 and 2012.

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Agency IQ

APRIL 8, 2024

Since these issues could occur during the investigational phase of clinical development as well as in the post-marketing setting—and product status could very well differ by country/region—ICH members determined that these guidelines should be developed to facilitate the exchange of information in both settings.

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Codon

MARCH 24, 2024

Novo Nordisk’s market capitalization ($442B) is already larger than the GDP of Denmark ( $404B ), the country where the company is headquartered. The market for semaglutide-based products is projected to swell to $71B in less than a decade. market with Wegovy will, by 2030, require about one million liters of production capacity.

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Agency IQ

OCTOBER 27, 2023

2050-AH28 National Emissions Standards for Hazardous Air Pollutants From Secondary Lead Smelting Proposed Rule Stage The Risk and Technology Review (RTR) for the Secondary Lead Smelters NESHAP (Subpart X) was promulgated on January 5, 2012 (77 FR 555). The Agency is now reconsidering that action. 2070-AL08 San Joaquin Valley PM2.5

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The Pharma Data

MARCH 31, 2023

Unitaid is working with implementing partners to ensure optimal use as part of a PrEP package that enables choice, and with the Coalition and other international partners to make long-acting PrEP options equitably accessible as quickly as possible.” Shionogi became a ViiV shareholder in October 2012. Access the sublicence agreements.

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Agency IQ

MARCH 29, 2024

The EPA is also proposing our response to a petition regarding the continued validity of EPA’s 2012 determination (and September 2017 affirmation) that participation in the Cross State Air Pollution Rule (CSAPR) meets the Regional Haze Rule’s criteria for an alternative to the application of source-specific BART.

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Agency IQ

JUNE 16, 2023

0910-AI84 December 2023 Final Rule Stage Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

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Agency IQ

DECEMBER 1, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

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FDA Science Regulations Production 40

Agency IQ

OCTOBER 27, 2023

December 2023 Fixed-Combination and Co-Packaged Drugs: Applications for Approval and Combinations of Active Ingredients Under Consideration for Inclusion in an Over-the-Counter Monograph (Final Rule) The final rule amends FDA regulations on fixed-combination prescription and nonprescription drugs.

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FDA Science Regulations Production 40

Agency IQ

DECEMBER 15, 2023

For this routine MUR, EPA will only consider new methods or method revisions for which a complete, acceptable method package has been received by January 7, 2022. This routine Methods Update Rule (rMUR) was proposed in February 2023. EPA is not considering methods for new analytes in this routine MUR.

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The Pharma Data

MAY 14, 2021

After having emergency surgery in 2012, I lost 10 pounds which got me down to my pre pregnancy weight, but I was not fit and strong, I was tired. She inspires clients to change their physique and their minds more than any diet, or weight loss plan on the market. Everyday, Dawn brings motivation and passion to her gym.

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Agency IQ

OCTOBER 20, 2023

PFAS are used to repel water, oil, stains, and increase durability, and are found in a wide array of consumer and industrial products including non-stick cookware, fabric treatments, food packaging, cleaners, textiles, leather, cosmetics, paper and paints, fire-fighting foams (AFFF), and wire insulation.

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Agency IQ

JUNE 16, 2023

The EPA is also proposing our response to a petition regarding the continued validity of EPA’s 2012 determination (and September 2017 affirmation) that participation in the Cross State Air Pollution Rule (CSAPR) meets the Regional Haze Rule’s criteria for an alternative to the application of source-specific BART.

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Agency IQ

JULY 28, 2023

On March 27, the FDA finalized a transition guidance document covering products that had been marketed under enforcement discretion policies during the PHE. First, by March 2021, manufacturers were expected to conclude a risk assessment of their approved or marketed products to assess the risk of nitrosamines.

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Drug & Device Law

JULY 31, 2023

2012), computer code was not a “product” for purposes of the National Stolen Property Act, 18 U.S.C. no[r] a marketing product” under Lanham Act). 2012 WL 5932437 (N.D. 27, 2012), limited the undefined term “product” in an Alabama sales commission statute to tangible things, excluding franchise rights. at 1293-94.

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Drug & Device Law

MAY 30, 2022

2012) (no proof that hypothetical “Dear Doctor letter” or on-product warning would have causal effect given that risk had arisen only once in implanter’s several thousand similar surgeries) (applying Tennessee law); Eck v. In In re Plavix Marketing, Sales Practices & Products Liability Litigation , 2017 WL 4838842 at *6-7 (D.N.J.

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Drug & Device Law

JUNE 6, 2022

2012), it had to apply the rule. 2012 WL 12848432, at *4 (E.D. 4, 2012) (no causation were, “[u]nderstanding the known risks,” the prescribing physicians testified that “they stand by their decisions to prescribe”), aff’d , 747 F.3d 26, 2015); In re Plavix Product & Marketing Cases , 2017 WL 2882212, at *3 (Cal.

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Drug & Device Law

SEPTEMBER 12, 2022

The case alleged on-label drug use between 2009 and early 2012, purportedly leading to plaintiffs’ decedent’s suicide in 2013 – more than a year after use of the drug had ceased. The group requested that the FDA either withdraw marketing approval. . . citations omitted).

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Drug & Device Law

JANUARY 4, 2024

2012), we hailed it as the best decision of 2012. purchase, marketing, promotion, . . development, clinical testing or investigation, distribution, purchase, marketing, promotion, sale, purchase, or use” of an immune covered countermeasure. Hamilton , 372 S.W.3d 3d 140 (Tex. Well, that’s different. 247d-6d(b)(8).

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Drug & Device Law

MARCH 16, 2022

In Arizona, a manufacturer cannot be liable for punitive damages if the product was “designed, manufactured, packaged, labeled, sold or represented in relevant and material respects according to the terms of an approval, conditional approval, clearance, license or similar determination of a government agency.”

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Drug & Device Law

AUGUST 3, 2023

Way back in September 2012, we—in its Blog-specific veiled singular usage—did our first post. For instance, in 2012, the impacts of the decision in PLIVA, Inc. Plaintiffs did not even complain about the content of the package insert. Eleven years has also seen quite a bit of change in our space. Mensing , 564 U.S.

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