Agency IQ

JUNE 28, 2024

FDA draft guidance on addressing misinformation clears White House review A few months ahead of a potential administration transition, the White House has cleared (with changes) a new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products.

FDA 40

FDA Regulations Production Licensing 40

Agency IQ

MAY 28, 2024

New FDA guidance on addressing misinformation under White House review A new question-and-answer draft guidance document focused on “addressing misinformation” about regulated life sciences products is currently under administrative review at the White House’s Office of Information and Regulatory Affairs (OIRA).

FDA 40

FDA Regulations Production Licensing 40

Advarra

JUNE 14, 2024

A regulatory binder is essential for managing clinical trial documents, ensuring regulatory compliance, and facilitating audits. It organizes critical documents; provides easy access for trial monitors, auditors, and regulatory authorities; and serves as a reference for the research team.

Clinical Trials 40

Clinical Trials Trials Compliance FDA 40

Conversations in Drug Development Trends

AUGUST 9, 2024

Managing this complexity highlights the importance of global communication plans and constant communication with global regulators and keeping all required documentation up to date. Harmonizing regulatory requirements and complying with all relevant regulations are crucial for the success of adaptive MRCTs.

Trials 80

Trials Clinical Trials Regulations FDA 80

Agency IQ

FEBRUARY 15, 2024

MHRA selects eight technologies to help it test its new innovative devices pathway The British regulator and its partners just released the list of products and companies chosen to participate in the pilot of its Innovative Device Access Pathway (IDAP). device regulations and the pilot for innovative products. and abroad.

Regulations 40

Regulations Science Production Vaccine 40

FDA Law Blog: Biosimilars

AUGUST 9, 2023

DEA has amended its regulations to allow, upon request from a patient, the transfer of an EPCS between retail pharmacies for initial filling on a one-time basis only. Two licensed pharmacists must directly communicate the transfer. Instead, the patient must request that the prescriber send a new prescription to a different pharmacy.

Pharmacy 52

Pharmacy Regulations Licensing Licensing 52

Agency IQ

JULY 8, 2024

What We Expect the FDA to do in July and August 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. We will see if FDA is willing to accept those changes later this month.

FDA 40

FDA Science Regulations Production 40

The Premier Consulting Blog

NOVEMBER 20, 2024

This process can be initiated during the review period of the biologics license application (BLA) or new drug application (NDA) prior to approval. Note that pre-approval inspections for biologics are referred to as pre-licensing inspections (PLI).

Small Molecule 52

Small Molecule Drugs FDA Production 52

Agency IQ

JANUARY 4, 2024

Swissmedic reorg adds new focus on medical device market surveillance The Swiss regulator, Swissmedic, just announced a reorganization, with a new head of the medicinal product authorization and vigilance sector, but also a new and discrete medical devices surveillance sector. Read more about what the regulator plans for its database here.]

Marketing 40

Marketing Regulations Clinical Trials International 40

Agency IQ

AUGUST 2, 2024

What We Expect the FDA to do in August and September 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more. This is what OIRA is currently reviewing.

FDA 40

FDA Science Regulations Biosimilars 40

Agency IQ

JULY 12, 2024

FDA gives companies leeway to go after misinformation, but not free reign In a new revised draft guidance document, the FDA says it will allow life sciences companies to address misinformation about their products that is posted online. In regulation, intended use is defined at 21 CFR 201.128 for drugs and 21 CFR 801.4

FDA 40

FDA Regulations Production Science 40

FDA Law Blog: Biosimilars

JUNE 27, 2024

DEA recently revoked the registration of Coconut Grove Pharmacy (“Coconut Grove”), like Gulf Med Pharmacy also in Florida, for its failure to resolve prescribing red flags and document such resolution. Coconut Grove Pharmacy; Decision and Order, 89 Fed. 50,372 , 50,377 (June 13, 2024). 50,372 at 50,372-73. 21 C.F.R. §§ 1306.04(a),

Pharmacy 52

Pharmacy Drugs Regulations Compliance 52

Agency IQ

JUNE 2, 2023

What We Expect the FDA to do in June 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. An updated Unified Agenda: The Unified Agenda is the U.S.

FDA 40

FDA Science Regulations Production 40

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. FDA is also due to revise 24 other guidance documents at that time.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 3, 2024

What We Expect the FDA to do in May and June 2024 In this ongoing feature, AgencyIQ looks at public data to determine what the FDA is likely to do in the months ahead, including key deadlines, meetings, events, planned regulations, comment periods and more.

FDA 40

FDA Science Regulations Clinical Trials 40

Agency IQ

MAY 10, 2024

What life sciences companies need to know about NIST’s new AI guidance The National Institute of Standards and Technology (NIST) last week released four new documents on artificial intelligence, mostly focusing on generative AI (GAI). NIST has released four new initial draft documents on AI Up first: Meet NIST’s work so far.

Science 40

Science FDA Production Regulations 40

Agency IQ

SEPTEMBER 29, 2023

What We Expect the FDA to do in October 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. FDA is also due to revise 24 other guidance documents at that time.

FDA 40

FDA Science Regulations Production 40

Agency IQ

MAY 31, 2024

Unpacking FDA’s long-awaited platform technology designation program and guidance Months overdue, the FDA’s Platform Technologies Designation guidance document has just been published by the agency. AgencyIQ breaks down what the designation means for sponsors and its limits for product sponsors. which would never be acceptable.

Science 40

Science FDA Production Licensing 40

Agency IQ

JUNE 29, 2023

What We Expect the FDA to do in July 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.

FDA 40

FDA Science Regulations Production 40

Agency IQ

APRIL 26, 2024

For context, while prescription drug products are required to comply with FDA’s regulatory requirements around labeling and approval (see 21 CFR 201 ), promotional materials and advertisements are regulated differently (under 21 CFR 202.1(1)(2) Read AgencyIQ’s analysis of this guidance here.]

Biosimilars 40

Biosimilars Science FDA Licensing 40

Advarra

JULY 19, 2022

A: For all vendors, having documented qualifications prior to use is important. For GMP vendors, documented reviews of records such as analytical testing and batch records, is also important. The auditor prepares by reviewing relevant information, such as contracts, as well as select QMS documents and records.

Packaging 52

Packaging FDA Trials Regulations 52

Agency IQ

SEPTEMBER 1, 2023

FDA finalizes guidance on oversight of RWE studies, making several significant changes The FDA today finalized a much-anticipated guidance document on how sponsors of drugs and biologics can oversee and make use of their non-interventional studies involving real-world data and evidence.

FDA 40

FDA Science Regulations Production 40

The Pharma Data

AUGUST 20, 2020

Poor regulation of antibodies tests – that could indicate if someone has had coronavirus – could be putting the public at risk, doctors have warned. “These regulations aren’t fit for purpose and don’t protect the public from bad tests,” he said. Image copyright. Getty Images.

Clinical Trials 52

Clinical Trials Regulations Doctors Government 52

The Pharma Data

JANUARY 10, 2021

Download the slideshow of meetings on the Company website, in the Documentation section dedicated to investors: www.valbiotis.com/en/documents/. Its products are intended to be licensed to players in the health sector. Its products are intended to be licensed to players in the health sector.

International 40

International Pharmaceutical Companies Disease Licensing 40

The Pharma Data

JANUARY 10, 2021

These forward-looking statements speak only as of the date of publication of this document. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. For more information, please contact: SOURCE: MorphoSys AG via EQS Newswire. Source link.

Clinical Development 52

Clinical Development Clinical Trials Clinical Supply Trials 52

The Pharma Data

DECEMBER 15, 2020

This is an important step towards a licensing agreement for Lipidor drug candidates, AKP01 and AKP02, for the treatment of psoriasis. According to the first target milestone, the production unit shall be ready to manufacture so-called stability batches for registration documentation during the first half of 2021.

Production 52

Production Laboratories Licensing Licensing 52

The Pharma Data

DECEMBER 12, 2020

Morgan Cazenove”) each of which are authorised by the Prudential Regulation Authority and regulated by the Financial Conduct Authority and Prudential Regulation Authority in the UK are each acting as financial adviser exclusively for AstraZeneca and no one else in connection with the matters set out in this announcement.

Regulations 75

Regulations International Disease Small Molecule 75

FDA Law Blog: Biosimilars

DECEMBER 11, 2023

1] Yet FDA’s conclusions about the Agency’s ability to regulate the entire laboratory industry are based on fundamentally flawed assumptions about the number of entities and tests that will be subject to FDA regulation. 5] This stratification, though, assumes that LDTs will follow the same pattern as IVDs currently regulated by FDA.

FDA 67

FDA Laboratories Regulations Production 67

FDA Law Blog: Biosimilars

FEBRUARY 29, 2024

156, as added by the 1984 Hatch-Waxman Amendments, for certain FDA-regulated products. 156 or case law that would support extension of the ‘929 patent that claims the product despite revocation of the biologics license application. According to documents in the PTO’s Patent Center, Lilly has not yet filed a response.

FDA 57

FDA Production FDA Approval Compliance 57

Advarra

FEBRUARY 28, 2023

Not all data generated in a research study will constitute “scientific data.” Researchers are not expected to share data that are not necessary to, or not of sufficient quality to, validate and replicate the research findings.

Research 52

Research Licensing Licensing Regulations 52

Agency IQ

JANUARY 12, 2024

BY AMANDA CONTI | JAN 10, 2024 9:29 PM CST Quick background: Goal dates under the Prescription Drug User Fee Act (PDUFA) The FDA collects user fees as part of an essential bargain between regulators and industry. According to Downey, the timeline of pre-license inspections for biologics can create challenges.

FDA 40

FDA Drugs Production Licensing 40

The Pharma Data

JANUARY 25, 2021

Further to the update outlined in the Company’s results for the year ended 31 December 2019, Secura Bio, Inc. (“Secura Bio”), the licensor of panobinostat, the API component of MTX110, has twice declined an invitation to withdraw its purported termination of the license. We are well positioned for a productive 2021.”

Licensing 52

Licensing Licensing Production Regulations 52

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). The regulators were off to a slow start, with just three total approvals in the first two months of 2024. Most NMEs approved so far this year relied on one pivotal trial.

Clinical Trials 52

Clinical Trials Trials Science FDA 52

Agency IQ

SEPTEMBER 29, 2023

Regulators wanted input on questions related to data access and re-use, to inform its legislative framework on common European data spaces. Two intertwined proposals have been laid out – a regulation on data governance and the proposed data act. Data intermediation service is defined in Regulation (EU) 2022/868.

Regulations 40

Regulations Government Production International 40

Agency IQ

JANUARY 26, 2024

Though regulations guide some aspects of how expiration dates are determined, the agency has but limited power to extend those dates unilaterally. As part of current good manufacturing practice (cGMP) regulations, drugs are required to bear an expiration date determined by “appropriate stability testing,” according to 21 CFR 211.137.

Science 40

Science FDA Production Packaging 40

Agency IQ

JUNE 2, 2023

The regulator sent the rule to the White House’s Office of Information and Regulatory Affairs (OIRA) on October 4, 2022. The PMI itself would be a one-page document that would include a standardized format and content, and would be subject to FDA review and approval. The format of the PMI : At just one page (8.5×11

FDA 40

FDA FDA Approval Production Regulations 40

The Premier Consulting Blog

NOVEMBER 16, 2022

Although novel excipients can be a part of any new drug application (NDA) or biologics license application (BLA) development program, they seem to be more common with the 505(b)(2) pathway, since many companies use cutting-edge delivery technologies to solve issues associated with previously approved drugs.

FDA 52

FDA Packaging Production Compliance 52