pharmaphorum

JUNE 10, 2022

Devices, like pharmaceuticals, are divided into risk categories with heavier or lighter regulation depending on the risk to the patient. You have a pacemaker on one end and a tongue depressor on the other, and then FDA has to figure out a regulatory scheme that takes into account every one of them, again, without stifling innovation.”.

Regulation 133

Regulation Production Life Science Drugs 133

XTalks

NOVEMBER 28, 2023

The biosimilar industry today is marked by rapid advancements, regulatory evolution and growing market acceptance. However, it is important for all stakeholders to realize that the FDA interchangeability designation is a legal distinction, not a clinical one. Newcomer: I think multiple factors come into play at the end of the day.

Production 98

Production Marketing Development Pharmacy 98

pharmaphorum

SEPTEMBER 29, 2022

If so, developers must develop and execute on a regulatory strategy. Determining whether a product is a medical device subject to FDA regulation necessarily begins with understanding the FDA regulatory definition of ‘medical device’. Food and Drug Administration (FDA) regulation as a medical device. General Wellness Products.

Development 104

Development Regulation Production Life Science 104

Drug Channels

JULY 18, 2022

You'll return to the office having mastered complex regulatory guidelines to deliver compliant government pricing and reporting programs. Don’t miss the chance to conquer the complex, ever-evolving regulatory guidelines and accelerate your career by sourcing world-class content and everyone who matters in Medicaid.

Drugs 60

Drugs Regulation Manufacturing Medicine 60

The Pharma Data

NOVEMBER 3, 2020

The Panel has accepted the addition of a permanent Category I CPT procedure code to replace the currently available Category III CPT code (0356T) for the administration of drug-eluting intracanalicular inserts, including DEXTENZA® (dexamethasone ophthalmic insert) 0.4 mg, effective January 1, 2022. mg, effective January 1, 2022.

Clinical Trials 52

Clinical Trials Clinical Trials FDA Approval Production 52

Advarra

SEPTEMBER 14, 2023

GxP in Clinical Trials To yield the best possible outcomes for clinical trials, GxP guidelines and compliance regulations assures regulatory agencies the safest and most productive research efforts are being delivered to the market. Working together, the U.S.

Clinical Research 52

Clinical Research Compliance Research Clinical Trials 52

XTalks

MARCH 4, 2024

The robotic-assisted surgery device was submitted via the FDA’s De Novo Classification Process , which provides a pathway to Class I or Class II classification for medical devices with no current legally marketed predicate device.

Marketing 52

Marketing Compliance Development Drugs 52

Drug Channels

OCTOBER 5, 2020

Strategies for Field Team Compliance and Virtual Monitoring Choose from Two In-Depth Tracks and Interactive Roundtables on: Legal and Compliance Innovation and Operations Critical Insights on Overcoming the Challenges and Complexities Amid a Shifting Industry from: Evan Panich, Assistant United States Attorney , U.S. Register today.

Compliance 52

Compliance Drugs Medicine Production 52

Drug Discovery World

AUGUST 3, 2023

What is the regulatory landscape of medical cannabis? Across the border in Canada, cannabis is legal for both recreational and medicinal purposes. There are five categories, each containing five cannabis scientists. Examples of people on the Power List include Susan Audino in the Analytical Heroes category.

Medicine 52

Medicine Scientist Production Regulation 52

FDA Law Blog

JANUARY 2, 2022

FDA indicates that they receive regulatory submissions with such computational modeling, but the submissions “often lack a clear rationale for why models can be considered credible for the context of use.” For regulatory submissions, the Draft Guidance recommends inclusion of a Credibility Assessment Report. Draft Guidance at 4.

In-Vivo 52

In-Vivo Development Engineer Clinical Trials 52

FDA Law Blog

JANUARY 2, 2022

FDA indicates that they receive regulatory submissions with such computational modeling, but the submissions “often lack a clear rationale for why models can be considered credible for the context of use.” For regulatory submissions, the Draft Guidance recommends inclusion of a Credibility Assessment Report. Draft Guidance at 4.

In-Vivo 40

In-Vivo Regulation Development Engineer 40

WCG Clinical

DECEMBER 13, 2023

When dietary supplements are classified as drugs, they do not have the same IND exemption pathway as legally marketed drugs, and sponsors may be required to obtain an IND. This is true regardless of whether the product is legally marketed as a food or a dietary supplement.

Regulation 52

Regulation Research Production Compliance 52

Pharmaceutical Technology

JULY 25, 2022

Despite this, specialty generics are expected to be the domain of a handful of companies with the necessary manufacturing capabilities and legal backing needed for entering the market. This also includes biologics and biosimilars, which go through a different regulatory journey. Strong legal footing and manufacturing base vital.

Drugs 298

Drugs Manufacturing Production Pharmacy 298

Advarra

JUNE 16, 2022

The CTA is a legally binding agreement executed between sponsors and sites; one meant to protect both parties’ rights and interests. Sponsors and Sites : Collect and Exchange Regulatory Documents and Critical Submissions . They fall into three general categories: . Federal/National Regulatory (i.e. SOP requirements .

Clinical Trials 52

Clinical Trials Clinical Trials Trials Research 52

FDA Law Blog

AUGUST 17, 2022

And FDA provided no dividing line between self-fitting and regular OTC, leaving the self-fitting hearing aid category vulnerable to evasion. Legally marketed devices that do not need a new 510(k) must comply with these regulations by April 14, 2023. (FYI, FDA does not use the term “regular hearing aids,” but we are for simplicity.)

Licensing 40

Licensing Licensing Regulation Marketing 40

FDA Law Blog

AUGUST 3, 2022

Not yet understanding how important you’d become, you entered the regulatory world without a name – the Agency simply referred to you as “home brew” products. These products are subject to the same regulatory requirements as any unapproved medical device”). Mullen — Happy Birthday Laboratory Developed Tests (LDTs).

In-Vitro 98

In-Vitro Regulation Compliance Production 98

pharmaphorum

JANUARY 4, 2023

The Proposal cites a number of reasons and studies that contributed to the desire for regulatory reform in the health data sector. Further, there are question marks around how the secondary use concept will sit alongside the GDPR, under which a legal basis is required for data users to process health data for secondary uses.

Regulation 98

Regulation Research Development Genome 98

pharmaphorum

JANUARY 12, 2021

Whilst regulatory approval is only a starting step on market access, the UK has made steps to put the UK on the priority list for companies seeking marketing authorisation. A key commitment in the deal is to reach the upper quartile of uptake in relation to comparator countries for the five highest health gain categories of treatments.

Marketing 81

Marketing Medicine Branding Production 81

FDA Law Blog

OCTOBER 6, 2023

The end of enforcement discretion The PR proposes to phase out LDT “enforcement discretion” over a period of four years, after which most LDTs will be subject to all applicable medical device regulatory requirements. Future blog posts will analyze FDA’s legal authority as well as FDA’s claimed public health need for LDT regulation.

In-Vitro 64

In-Vitro Regulation Production Compliance 64

Pharma Marketing Network

NOVEMBER 4, 2020

RJ (PMN): One of the things I’m thinking about as you’re describing the kind of multiple permutations that could evolve and I’ve seen this in some of the examples you say to be for about like AI creating its own musical composers which have gotten really quite good and and fascinating. So Theraflu, Advil, Biotene and ChapStick.

Branding 52

Branding Marketing Regulation Production 52

The Pharma Data

JULY 6, 2021

In particular, these include statements relating to future actions, prospective products or product approvals, future performance or results of current and anticipated products, sales efforts, expenses, the outcome of contingencies such as legal proceedings, dividend payments and financial results.

Sales 52

Sales Vaccination Vaccine Production 52

Placebo Control

JULY 31, 2013

Everyone I work with in pharma trials is painfully aware of the regulatory environment they work in. FDAAA compliance is a given, a no-brainer: large internal legal and compliance teams are everywhere, ensuring that the letter of the law is followed in clinical trial conduct.

Pharma Companies 40

Pharma Companies Trials Compliance Clinical Trials 40