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.

Regulations 40

Regulations Trials Science Clinical Trials 40

The Premier Consulting Blog

MAY 4, 2023

The global ophthalmic drugs market size was valued at $33.81 The FDA has determined that ophthalmic dispensers are now regulated as devices, and the drug and device together are regulated as a combination product. billion in 2022 and is expected to grow approximately eight percent from 2023 to 2030 [1].

FDA 52

FDA Packaging Compliance Regulations 52

FDA Law Blog: Biosimilars

AUGUST 4, 2023

Because anabolic steroids are also abused to enhance athletic performance and increase muscle strength, Congress has enacted three laws regulating anabolic steroids: the Anabolic Steroid Control Acts of 1990 and 2004, and the Designer Anabolic Steroid Control Act of 2014 (“DASCA”). 50,036 (Aug. at 50,037 codified at 21 C.F.R.

Regulations 52

Regulations Production Clinical Trials Drugs 52

FDA Law Blog: Biosimilars

MAY 6, 2024

Baumhardt, Senior Medical Device Regulation Expert & Adrienne R. Lenz, Principal Medical Device Regulation Expert — FDA recently issued a draft guidance which would update the agency’s Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions guidance. are cybersecure. are cybersecure.

FDA 105

FDA Regulations Marketing Drugs 105

Perficient: Drug Development

NOVEMBER 14, 2023

Data privacy has become an increasingly complex subject, especially with the introduction of the California Consumer Privacy Act (CCPA) and similar regulations emerging in other states. Non-compliance with these regulations can result in hefty fines, as seen with Sephora’s recent $1.2

Compliance 98

Compliance Regulations Production Marketing 98

Drug Discovery World

FEBRUARY 1, 2023

It is estimated that there will be 340,000 medicinal cannabis users in Europe in 2022 alone, and the overall market is estiated to grow over 500% over the next three years – with the market value in Germany alone poised to hit over €7 billion by 2027 1. Only with more evidence-backed indications will the medicinal market boom.

Clinical Trials 130

Clinical Trials Trials Pharmaceutical Companies Doctors 130

FDA Law Blog: Biosimilars

MAY 15, 2023

By Riëtte van Laack — For those readers unfamiliar with the regulation of animal food ingredients in the United States, below is a brief background. In the United States, animal food (feed) regulations are enforced by state and federal regulatory officials. AAFCO develops model regulations, that serve as model for the states.

Regulations 45

Regulations FDA Approval FDA Production 45

The Pharma Data

JANUARY 24, 2021

The global esophageal cancer drugs market is estimated to grow by USD $1.5 Completion of the transaction is subject to customary closing conditions, including completion of due diligence, negotiation of definitive agreements and receipt of all necessary approvals. Persons”, as such term is defined in Regulations under the U.S.

FDA 52

FDA Drugs Clinical Development Pharmaceutical Companies 52

Agency IQ

JULY 8, 2024

In a new final rule, FDA carves out a regulatory niche for medical gases Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Following this process, FDASIA directed the FDA to submit a report to Congress summarizing its findings.

FDA 40

FDA Regulations Production Packaging 40

Agency IQ

OCTOBER 27, 2023

MHRA, FDA and Health Canada offer “guiding principles” for predetermined change control plans Regulators from the U.S., The regulators suggest that PCCPs need to be transparent, risk-based, bounded and operate throughout the product life cycle. Internationally, regulators are building a framework AI/ML in regulated products.

FDA 40

FDA Regulations International Production 40

Agency IQ

JUNE 28, 2024

Generally, how have states attempted to regulate PFAS? States are attempting to regulate PFAS in a variety of ways, including via multiple in-state regulatory and legislative avenues. Used products and used product components are officially exempted from the regulations, as well as manufacturers that employ 25 or fewer people.

Production 40

Production Regulations Compliance Packaging 40

Drug Channels

FEBRUARY 21, 2023

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

Pharmacy 97

Pharmacy Specialty Pharmacies Licensing Licensing 97

FDA Law Blog: Biosimilars

JUNE 28, 2023

The proposed legislation appears to be an effort to resolve issues created by FDA’s Center for Veterinary Medicine’s (CVM) interpretation of the Federal Food, Drug, and Cosmetic Act (FDC Act) definition of food. On October 18, 2022, CVM held a virtual listening session on the regulation of animal foods with certain types of claims.

Regulations 45

Regulations Production Drugs Disease 45

FDA Law Blog: Biosimilars

MARCH 5, 2024

Many states have proposed but failed to enact legislation regulating the labeling of APPs, in some cases due to concerns of potential legal challenges based on federal preemption claims. Arizona’s House of Representatives passed a similar bill on February 22 of this year, which is now pending review by the State Senate.

Protein Production 59

Protein Production Production DNA Regulations 59

Agency IQ

JANUARY 12, 2024

BY WALKER LIVINGSTON, ESQ | JAN 8, 2024 9:33 PM CST TSCA and PFAS The Environmental Protection Agency (EPA) implements the Toxic Substances Control Act (TSCA), which provides the basis for much of the chemical regulation in the United States. An AgencyIQ explainer on the EPA’s definition of PFAS may be reviewed here.]

Regulations 40

Regulations Production Government Research 40

Drug Channels

FEBRUARY 22, 2022

Pharmacies and Pharmacy Benefit Managers is a definitive, nonpartisan resource that includes the most current information about pharmacy dispensing channels, third-party payers, pharmacy benefit managers (PBMs), patients’ financial contributions, government regulations, and much more.

Pharmacy 96

Pharmacy Specialty Pharmacies Biosimilars Licensing 96

Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH | JUL 10, 2024 3:47 PM CDT Regulatory background: The FDA is responsible for overseeing information about regulated products. The FDA is responsible for ensuring that medical products are adequately labeled in accordance with federal regulations, including the product’s “intended use” and relevant safety information.

FDA 40

FDA Regulations Production Science 40

Agency IQ

JUNE 7, 2024

Almost 10 years late, the new framework’s arrival will represent significant changes in the regulation of these pesticide substances. Active substances that have been approved for use in the EU are listed in the Annex of Regulation (EU) No 540/2011; currently, approximately 450 entries are listed.

Regulations 40

Regulations Animal Testing Production Marketing 40

The Premier Consulting Blog

NOVEMBER 8, 2022

With the promise of simplified and improved treatments, the $118 billion combination-product market is projected to increase at a compound annual growth rate (CAGR) of 8.8%. metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e) metered-dose inhaler) However, the four-part definition in 21 CFR 3.2(e)

Production 52

Production Packaging Efficacy & Potency FDA 52

Drug Discovery World

JANUARY 31, 2023

Mature organisations must race to deliver key new patient therapeutics while meeting market revenue expectations. In addition, many systems are heavily focused on execution rather than process definition. These XML schemas are designed to better facilitate the exchange of process definitions while retaining ISA-88 compliant structures.

Production 246

Production Engineering Pharmaceutical Companies Clinical Trials 246

Agency IQ

JUNE 7, 2024

dietary supplement market has grown into a vast industry that has little in common with its DSHEA-era predecessor. Under DSHEA, manufacturers are responsible for ensuring their products are safe prior to release to the market. An NDI is defined as a dietary ingredient not marketed before October 15, 1994.

FDA 40

FDA Science Production FDA Approval 40

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. Life Sciences Vision.

Regulations 40

Regulations Production Science Vaccine 40

Advarra

AUGUST 31, 2022

In response to a growing demand for faster, approved, and cost-effective medical devices for chronic diseases, medical device manufacturers and emerging biotech companies are facing increasingly complex pathways to successfully bring their innovative ideas to the market. Meeting with the Regulators. Regulators are not your adversaries.

Research 52

Research Regulations Clinical Trials Trials 52

Agency IQ

MAY 10, 2024

FDA holds the line on remanufacturing definitions in newly finalized guidance Almost three years after the initial draft, the FDA has now finalized guidance describing the differences between medical device “servicing” and “remanufacturing” and each activity’s quality system implications. That draft guidance came out in 2021.

FDA 40

FDA Regulations Compliance Production 40

Agency IQ

NOVEMBER 3, 2023

Unfortunately, there is no regulatory body that governs the terminology used in this space, although there are definitions that are generally accepted by the scientific community. Postbiotic: “Preparation of inanimate micro-organisms and/or their components that confers a health benefit on the host,” according to the ISAPP definition.

Therapies 40

Therapies Science FDA Production 40

Drug Discovery World

FEBRUARY 14, 2023

MT: In terms of regulation, what milestones need to be reached before completely open access to this data is possible? MT: In terms of regulation, what milestones need to be reached before completely open access to this data is possible? Why does regulation matter? RBC Capital Markets.

Regulations 130

Regulations Research Disease Science 130

FDA Law Blog: Biosimilars

OCTOBER 18, 2023

Lenz, Principal Medical Device Regulation Expert — Although it seems not widely known outside of the medical device industry, FDA can require sponsors to include clinical data as part of a 510(k) submission. These include: results of pre- and post-market clinical investigation(s) of the device (i.e., By Adrienne R.

FDA 64

FDA Regulations Clinical Trials Marketing 64

The Premier Consulting Blog

NOVEMBER 20, 2023

The FDA is proposing a change to its regulations to explicitly classify In Vitro Diagnostics (IVDs) as devices under the Federal Food, Drug, and Cosmetic Act (FD&C Act), irrespective of the manufacturer being a laboratory that previously conducted business and was certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA).

Laboratories 52

Laboratories FDA Clinical Development Regulations 52

Agency IQ

MARCH 25, 2024

AgencyIQ Guidance Tracker: European medical device and diagnostics guidance documents With the many moving parts of the European medical device and IVD regulations, it can be difficult to keep up on planned guidance and other publications, published documents and document revisions. Our new resource aims to help make this a little bit easier.

Regulations 40

Regulations Compliance Production Marketing 40

Agency IQ

JUNE 26, 2023

incentives for rare disease-focused drug development were first enacted in 1983 under the Orphan Drug Act, including market exclusivities (7 years of marketing exclusivity), waivers from certain user fees, and tax credits for certain development activities (currently worth 25% of development costs). regulators. In the U.S.,

FDA 40

FDA Disease Regulations Production 40

Drug Target Review

OCTOBER 31, 2023

Regulatory affairs workers get to tell a story about a drug to the regulators and – keeping the end in mind, which is the drug label or prescribing information – is a good way to communicate with regulators. I’ve been lucky to have seen several drugs make it all the way to market. Every drug has a story: an end game.

Cell Biology 107

Cell Biology Pharmaceuticals Science International 107

Agency IQ

JANUARY 26, 2024

Carper noted that the issues with how the EPA has implemented TSCA has led to “grievances” from both the chemical industry and environmental advocates, as the flow of chemicals to market and regulation of harmful chemicals has slowed. ED MARKEY (D-MA) raised questions that heavily dealt with trichloroethylene (TCE).

Testimonials 40

Testimonials Regulations Science Marketing 40

Agency IQ

AUGUST 11, 2023

Given this significance, it’s worth analyzing its chaotic regulatory history, examining the implications of the risk assessment document itself, and projecting how this controversial active substance is likely to be treated by EU regulators going forward.

Regulations 40

Regulations Marketing DNA Production 40

Agency IQ

NOVEMBER 3, 2023

A 2017 European Parliament resolution called on the European Commission and the European Council “to formulate a better definition of the concept – and analyse the causes – of shortages of medicines.” Regulation (EU) 2022/123 became applicable on March 1, 2022, with the exception of most provisions related to medical devices.

Regulations 40

Regulations International Pharmaceuticals Production 40

FDA Law Blog: Biosimilars

SEPTEMBER 30, 2024

Gaulkin — In May 2023, we posted about a CMS proposed regulation that sought to make a wide variety of changes to the Medicaid Drug Rebate Program (MDRP), including a new “price verification survey,” and a controversial proposal to require “stacking” of discounts to different customers when determining best price.

Regulations 59

Regulations Drugs International Pharmacy 59

Agency IQ

FEBRUARY 12, 2024

What’s going on in the world of PFAS – early 2024 edition This feature from AgencyIQ focuses on the wide world of per- and polyfluoroalkyl substance regulation, legislation, and litigation around the United States. An AgencyIQ explainer on the EPA’s definition of PFAS may be reviewed here.] since June 21, 2006.

Regulations 40

Regulations Packaging Production Doctors 40

Agency IQ

MAY 26, 2023

The proposal also amends the regulations for low volume exemptions (LVEs) and low release and exposure exemptions (LoREXs) and removes eligibility for these exemptions for new per- and polyfluoroalkyl substances (PFAS) and other persistent, bioaccumulative, and toxic (PBT) substances.

Regulations 40

Regulations Engineering Production Government 40