Agency IQ

AUGUST 2, 2024

An earlier iteration of that report detailed how the agency wanted to change some of its practices surrounding the publication of guidance documents. However, the draft document was somewhat FDA-focused, and industry asked the agency to incorporate other ideas into the final version. This is what OIRA is currently reviewing.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JANUARY 12, 2024

These windows depend on whether the new drug application (NDA) or biologics license application (BLA) is a new molecular entity, and if the application has received standard review (10 months, plus 2 months of administrative time) or priority review (6 months, plus 2 months of administrative time).

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FDA Drugs Production Licensing 40

Agency IQ

MAY 3, 2024

FDA’s Diversity Action Plan guidance: The FDA’s hotly-anticipated revised draft guidance document is currently under review at the White House’s Office of Information and Regulatory Affairs (OIRA), and we anticipate that it will be published over the next two months. Read the full list of documents on FDA’s Unified Agenda here.]

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FDA Science Regulations Clinical Trials 40

Agency IQ

AUGUST 4, 2023

New MHRA Windsor Framework documents guide post-Brexit flow of medicines for U.K., The document specifically notes that it applies to “medicinal products for human use intended to be placed on the market in Northern Ireland in accordance with Article 6 of Directive 2001/83/EC,” the current European pharmaceutical legislation.

Packaging 40

Packaging Licensing Licensing Regulations 40

Agency IQ

JANUARY 19, 2024

approval and discussion with the FDA, the company announced in December 2023 that it intends to re-submit the biologics license application in the U.S. The clinical package, safety and label were not affected. Based on the E.U. Ebglyss (lebrikizumab; Almirall) received a Complete Response Letter (CRL) from the U.S. FDA in October 2023.

Biosimilars 40

Biosimilars FDA Production Treatment 40

Agency IQ

NOVEMBER 3, 2023

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. In fact, the FDA has even developed a guidance document for “early clinical trials with live biotherapeutic products [LBPs].”

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Therapies Science FDA Production 40

Agency IQ

JANUARY 26, 2024

To support industry’s accurate identification and updating of drug expiration dates, the FDA has released a handful of guidance documents for industry. However, these documents are focused on targeted considerations and do not address the standard, overarching process of conducting product stability testing and expiration date identification.

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Science FDA Packaging Production 40

The Pharma Data

DECEMBER 17, 2020

These follow-on data provided the first definitive prospective evidence demonstrating anti-viral activity for a treatment regimen now available for COVID-19, and also further documented the ability of this treatment to decrease the need for further medical attention,” said George D. Yancopoulos , M.D.,

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The Pharma Data

AUGUST 6, 2020

See “Worldwide Pro Forma Revenue” in Quarterly Package of Financial Information for this quarter, which is available on bms.com/investors/financial-reporting/quarterly-results, for information on the revenue of the company and Celgene on a stand-alone basis for the prior-year period. In June, the company and Acceleron Pharma Inc. Regulatory.

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Production International Licensing Licensing 52

Agency IQ

OCTOBER 27, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. FDA is also due to revise 24 other guidance documents at that time. AgencyIQ November 18 Shutdown (?)

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FDA Science Regulations Production 40

Agency IQ

JUNE 16, 2023

The 51 regulations that FDA is currently working on The FDA today unveiled its much-anticipated Spring 2023 Unified Agenda, a document outlining the regulations the agency plans to release in 2023 and beyond. Some of the affected former NDAs were approved using drug master files (DMFs). the drug and device) of the combination product.

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Regulations FDA Science Production 40

Agency IQ

DECEMBER 1, 2023

While the FDA previously published a similar version of this document, Congress gave FDA new authority to require these plans. Expect nearly every company to be closely reading this document when it’s eventually published. Note: If a link no longer works, it is likely because OIRA has since cleared the document.)

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FDA Science Regulations Production 40

Agency IQ

JULY 22, 2024

All products are received in one of two forms: A New Drug Application (or NDA, for pharmaceuticals) or a Biologics License Application (BLA, for biologics). AgencyIQ compiles these data using information in approval letters, labeling and review packages posted to the Drugs@FDA database. population.

Clinical Trials 52

Clinical Trials Trials Science FDA 52

Agency IQ

JANUARY 12, 2024

Most notably, in May 2022 the FDA issued a final guidance document clarifying who may submit a SIP proposal and which entities may import eligible prescription drugs. The supply chain could only contain three entities: The manufacturer, the Foreign Seller (who must also be a licensed wholesaler by Health Canada), and the importer.

FDA Approval 40

FDA Approval FDA Science Drugs 40

Agency IQ

JUNE 2, 2023

Within the realm of FDA-required labeling, there are currently a few different types of information a sponsor might develop specifically for patient use: medication guides, instructions for use (IFU), consumer medical information (CMI) and patient package inserts (PPI). The format of the PMI : At just one page (8.5×11

FDA 40

FDA FDA Approval Production Regulations 40

Agency IQ

JULY 12, 2024

The 53 regulations that FDA is currently working on The FDA on Friday unveiled its much-anticipated Spring 2024 Unified Agenda, a document outlining the regulations the agency plans to release in 2024 and beyond.

Regulations 40

Regulations FDA Science Production 40

Agency IQ

JUNE 16, 2023

The document contains much of the same information as previous Unified Agendas, and this piece will dive into some of the rules that the agency expects to publish in the next six months.

Regulations 40

Regulations Compliance Production Science 40

Agency IQ

JULY 28, 2023

It’s also possible that some of FDA’s commitments – and especially things like new guidance documents – might get delayed later into October. That’s because significant guidance documents typically require review and approval by the White House’s Office of Information and Regulatory Affairs (OIRA) prior to publication.

FDA 40

FDA Science Biosimilars Regulations 40

Drug & Device Law

DECEMBER 29, 2023

Plaintiff knew about it, too, since he signed an informed consent document mentioning it. Equally bad, Hrymoc effectively read a New Jersey statute, §2A:58C-5(c), which precludes punitive damages where a “device” was “licensed” by the FDA, out of existence. The device labeling specifically mentioned it.

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