ProRelix Research

JUNE 27, 2024

In the United States, The Food and Drug Administration (FDA) regulates and oversees clinical trials of food and dietary supplements and develops various regulations and guidelines for their use. The […] The post Food and Dietary Supplements Clinical Trials Regulations in USA appeared first on ProRelix Research.

Clinical Trials 52

Clinical Trials Regulations Trials FDA 52

BioPharma Drive: Drug Pricing

JUNE 17, 2024

One biotech executive called the Supreme Court’s decision a “very important win” for the industry, although new challenges to the FDA’s regulation of the drug could still be forthcoming.

FDA 107

FDA Regulations Drugs 107

Drug Discovery World

MARCH 30, 2023

Currently, only four preventive cancer vaccines have been approved by the Food and Drug Administration (FDA) for the prevention of Human Papillomavirus (HPV) and Hepatitis B virus (HBV) infection related cancers. The post Chinese regulator approves personalised cancer vaccine trial appeared first on Drug Discovery World (DDW).

Vaccine 130

Vaccine Regulations Trials Immune Response 130

FDA Law Blog: Biosimilars

JULY 23, 2024

Lenz, Principal Medical Device Regulation Expert — For several years, FDA has requested that sponsors of drug or biologic led combination products identify essential performance requirements (EPRs) related to the device constituent in their applications. By Adrienne R. does not use this term. does not use this term.

FDA 105

FDA Drugs Pharmacokinetics Production 105

Drug Discovery World

JANUARY 10, 2024

Speaking on the recent FDA statement, Bruce Levine, ISCT Immediate Past President and Lead Author on the publication, stated: “The fundamental question from this report is whether or not there is a causal link between CAR-T therapy and these rare T cell malignancy cases and in how many patients.

FDA 148

FDA Therapies International Treatment 148

thought leadership

AUGUST 30, 2023

ProPharma's Regulatory Science experts take a deep-dive into FDA's Nitrosamine Impurity Regulations for NDSRIs including Acceptable Intake Limits.

Regulations 52

Regulations FDA Science 52

Drug Discovery World

AUGUST 21, 2023

Ipsen’s Sohonos (palovarotene) has become the first drug approved for patients with fibrodysplasia ossificans progressiva (FOP) in the US, following the granting of a marketing authorisation by the Food and Drug Administration (FDA). The EU’s regulator chose not to recommend the drug in January 2023.

FDA Approval 130

FDA Approval FDA Treatment Regulations 130

Agency IQ

AUGUST 30, 2024

FDA AdComm to discuss patient-centric informed consent The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

FDA 40

FDA Regulations Clinical Trials Production 40

Agency IQ

AUGUST 25, 2023

Cannabis groups to Congress: FDA should regulate CBD as a dietary supplement U.S. legislators have asked for help to reimagine how the FDA should regulate cannabidiol (CBD) following the agency’s determination that it could not make use of its existing legislative or regulatory authorities to do so.

Regulations 52

Regulations FDA Science 52

FDA Law Blog: Biosimilars

JUNE 10, 2024

Walsh — Among FDA-regulated establishments and stakeholders, there is one word that makes everyone go on edge – the dreaded FDA “inspection.” In FY2023, FDA conducted over 1000 inspections under the BIMO program. We also detail some of our recommended best practices to achieve success when FDA comes knocking.

FDA 111

FDA Compliance Laboratories International 111

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.

Regulations 52

Regulations FDA Science 52

FDA Law Blog: Biosimilars

MARCH 15, 2023

By Véronique Li, Senior Medical Device Regulation Expert — Earlier this month, FDA published a final rule to update the mammography regulations, issued under the Mammography Quality Standards Act of 1992 (MQSA) and the Federal Food, Drug, and Cosmetic Act (FD&C Act). It authorized FDA oversight over mammography facilities.

Regulations 59

Regulations FDA Doctors Government 59

Drug Discovery World

APRIL 4, 2023

The Food and Drug Administration (FDA) in the US has made several key drug decisions over the last few weeks. The drug was granted orphan drug designation by the FDA in May 2021. Here’s a summary.

FDA 130

FDA FDA Approval Small Molecule Therapies 130

FDA Law Blog: Biosimilars

MARCH 10, 2024

Last August the Food and Drug Administration (“FDA”)/Health and Human Services (“HHS”) recommended that the Drug Enforcement Administration (“DEA”) reschedule cannabis from schedule I under the federal Controlled Substances Act (“CSA”) to schedule III. The conference, held in Washington, D.C.,

Regulations 64

Regulations FDA Production Drugs 64

Chemical Biology and Drug Design

SEPTEMBER 30, 2023

Abstract Epigenetic regulation of genes through posttranslational regulation of proteins is a well-explored approach for disease treatment, particularly in cancer chemotherapy. Structural classification and regulatory functions of histone deacetylases and their inhibitors.

Regulations 100

Regulations FDA Treatment Disease 100

Agency IQ

AUGUST 30, 2024

By Laura DiAngelo, MPH The FDA’s Center for Devices and Radiological Health (CDRH) will soon convene its Patient Engagement Advisory Committee to discuss “patient-centered informed consent” policies – notably, not just for medical devices but for “FDA regulated medical products” writ large.

FDA 52

FDA Regulations Production 52

FDA Law Blog: Biosimilars

JANUARY 28, 2024

Gonzalez — In a new publication in the Washington Legal Foundation’s (WLF) Legal Backgrounder , we argue that FDA’s recent proposed rule regulating Laboratory Developed Tests (LDTs) is vulnerable to legal challenge, once finalized. But, as we detail in the WLF publication: “ the MDA supplies no such clear [congressional authorization].

Regulations 64

Regulations Laboratories Government FDA 64

FDA Law Blog: Biosimilars

APRIL 2, 2024

Koblitz — Every year, federal agencies submit a budget request to Congress to fund various agency initiatives, and every year FDA includes a list of legislative proposals that it would like to see come out of Congress. FDA believes this change would effectuate timelier and more cost-efficient generic drug development.”

FDA 104

FDA Biosimilars Production Regulations 104

Drug Discovery World

JANUARY 23, 2023

As an FDA-approved oral drug, the side-effects of cladribine are quite manageable and it has been well evaluated for pharmacokinetics. The post FDA-approved drug sensitises brain cancer cells to radiotherapy appeared first on Drug Discovery World (DDW).

FDA Approval 130

FDA Approval FDA Drugs Pharmacokinetics 130

Agency IQ

JULY 12, 2024

BY LAURA DIANGELO, MPH 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. Fill out the form to read the full article.

FDA 59

FDA Regulations Science Production 59

Agency IQ

AUGUST 2, 2024

By Alexander Gaffney, MS, RAC 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. Fill out the form to read the full article.

FDA 59

FDA Regulations 59

FDA Law Blog: Biosimilars

NOVEMBER 9, 2023

Food and Drug Administration (FDA) issued a proposed rule that would amend its prior notice regulations to add new information requirements and deadlines. Prior notice” informs FDA about the products it can expect to be offered for import into the country. By Sophia R. food supply and other food-related emergencies.

Regulations 52

Regulations FDA Compliance International 52

Advarra

JULY 26, 2022

Importantly, the 2018 Farm Bill preserved FDA authority to regulate products with cannabis or cannabis-derived compounds under the Federal Food, Drug, and Cosmetic (FD&C) Act and Section 351 of the Public Health Service Act. Some may wonder, is the FDA open to approving and funding research on cannabis?

Regulations 97

Regulations Research FDA FDA Approval 97

FDA Law Blog: Biosimilars

JANUARY 24, 2024

The American Conference Institute’s (“ACI’s”) popular “FDA Boot Camp”—now in its 42nd iteration—is scheduled to take place from March 13-14, 2024, at the SpringHill Suites NY Manhattan Times Square South, New York. Join the “Who’s Who” of the FDA Bar and don’t miss your opportunity to join their ranks! Join our co-chairs Kurt R.

FDA 59

FDA Regulations Science Drugs 59

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

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. Broadly, the rule sought to require the use of certain safeguards in the production, storage, and use of medical gases.

FDA 40

FDA Regulations Production Packaging 40

thought leadership

AUGUST 6, 2024

Why Does Pharmaceutical Product Labeling Matter? Do you know what’s in your product’s labeling and what it is saying about your product? More importantly, do you know why that matters?

Regulations 40

Regulations FDA Pharmaceuticals Production 40

Agency IQ

JULY 8, 2024

BY ALEXANDER GAFFNEY, MS, RAC 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. Fill out the form to read the full article.

FDA 59

FDA Regulations 59

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

The Premier Consulting Blog

DECEMBER 28, 2023

1] However, if certain criteria are met, many in vitro diagnostic (IVD) devices are released from IDE regulations. This blog post discusses how device studies are classified and explores scenarios where DVDs qualify for exclusion from IDE regulations. b) Exempt studies that do not require an IDE. Available at [link]. [2]

Regulations 52

Regulations FDA Production Compliance 52

Eye on FDA

OCTOBER 12, 2023

FDA announced this week the formation of a new advisory committee – the Digital Health Advisory Committee – for the purpose of providing the agency with advice on matters related to digital health technologies (DHT). FDA does not form new advisory committees all that often, making it a notable development in more than one respect.

FDA 74

FDA Clinical Trials Regulations Trials 74

Agency IQ

JUNE 28, 2024

BY AMANDA CONTI 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. This administrative review is last procedural step before the FDA can publish the document.

FDA 52

FDA Regulations Science Production 52

Advarra

JUNE 26, 2023

Food and Drug Administration (FDA) guidelines is critical to the success, failure, or delay of delivering life-changing therapies to market. A successful FDA inspection can pave the way for continued operations, product approvals, and in some cases, even accelerated go-to-market regulatory pathways.

FDA 52

FDA Compliance Regulations International 52

Agency IQ

MAY 28, 2024

BY LAURA DIANGELO, MPH 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 59

FDA Testimonials Regulations Science 59

FDA Law Blog: Biosimilars

FEBRUARY 26, 2024

Karst — While the Biologics Price Competition and Innovation Act (“BPCIA”) is inherently distinct from the Hatch-Waxman Act, many of the fundamental concepts FDA adopted as it enacted the Hatch-Waxman Act made their way into FDA’s implementation of the BPCIA. FDA borrowed this definition from 21 C.F.R.

FDA 59

FDA Biosimilars Production Regulations 59

Agency IQ

JULY 22, 2024

BY LAURA DIANGELO, MPH In April 2024, the FDA issued a final rule to update its regulatory approach to certain test products known as Laboratory Developed Tests (LDTs). AgencyIQ provides a status update for regulated industry. Fill out the form to read the full article.

FDA 59

FDA Laboratories Regulations Drug Development 59

Agency IQ

JULY 8, 2024

BY RACHEL COE, MSC Industry has been lobbying FDA and Congress to regulate medical gases different from other types of drug products since the 1970s. Nearly fifty years later, a final rule has made concessions industry has long been calling for, but retains reporting and safety provisions the agency deems important.

FDA 59

FDA Regulations Production Drugs 59