This site uses cookies to improve your experience. To help us insure we adhere to various privacy regulations, please select your country/region of residence. If you do not select a country, we will assume you are from the United States. Select your Cookie Settings or view our Privacy Policy and Terms of Use.
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Used for the proper function of the website
Used for monitoring website traffic and interactions
Cookie Settings
Cookies and similar technologies are used on this website for proper function of the website, for tracking performance analytics and for marketing purposes. We and some of our third-party providers may use cookie data for various purposes. Please review the cookie settings below and choose your preference.
Strictly Necessary: Used for the proper function of the website
Performance/Analytics: Used for monitoring website traffic and interactions
Butler — In a move FDA is calling “radical transparency,” the Agency announced on July 10, 2025 that it has published 200+ Complete Response Letters (CRLs) issued in response to marketing applications for drugs and biologics on its openFDA database. By Sarah Wicks & Michelle L.
The rules were implemented to enhance patient safety protections via revised drug handling, packaging, and delivery requirements. The rules include changes to the notification process, medication packaging, the handling of reports, and safety issues. Hyman, Phelps & McNamara, P.Cs
DEA seized five packages in Eagle Pass, Texas, identifying IMC Pro as the shipper containing 26.4 IMC Pro did not store or handle the packages nor maintain records about their contents. of 1-BOC-Piperidone and 138.66 of (2-Bromethyl) benzene. Both chemicals are used in the illicit manufacturer of fentanyl.
Food and Drug Administration (FDA) is already having ripple effects not just internally, but across the broader regulatory and life sciences communities and the public at large. However, not all information contained in FDA records is disclosable. However, not all information contained in FDA records is disclosable.
On an average, around 50 drugs are approved by the US Food and Drug Administration (US FDA) annually. This continuously growing pipeline of pharmaceutical drug products has inadvertently led to an increase in the demand for their associated primary packaging and Secondary Packaging solutions. . trillion in 2023.
To be clear, the minor changes are permitted only for OTC monograph drug products that are included in deemed final orders, and not for OTC monograph products that may remain on the market pending FDA monograph orders allowing or prohibiting such products.) The suitable reference product must be a capsule or tablet that is swallowed.
After a firm submits a 510(k) to FDA, FDA will request still more information after a first-pass review. According to the 2 nd Quarter FY2023 MDUFA V Performance Report , FDA issued a request for additional information (AI request) on the first FDA review cycle for 63% to 68% of 510(k)s submitted in FY2018 to FY2022.
In today’s global landscape, sustainability has emerged as a pivotal concern across various sectors including the pharmaceutical packaging industry. What is Sustainable Packaging / Green Packaging? The following figure presents the raw materials used by the sustainable packaging companies.
Mullen — More than five years after FDA first announced its plan to harmonize 21 CFR Part 820 with ISO 13485, on February 2, 2024, FDA finally issued the Quality Management System Regulation (QMSR) Final Rule. FDA further retained some definitions in the QSMR. Notably, Part 820 will look different. Revised § 820.3
The conference is the premier event on cosmetics and personal care products, where industry leaders will provide essential updates on compliance with Modernization of Cosmetics Regulation Act of 2022 (MoCRA), state legislative reforms, new FTC advertising guidelines, and FDA leadership changes. FDA Law Blog is a conference media partner.
Valentine — On November 22, 2022, FDA approved CSL Behring’s BLA for Hemgenix (etranacogene dezaparvovec), an AAV-based gene therapy for the treatment of adults with Hemophilia B who currently use Factor IX prophylaxis therapy, have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes.
FDA Law Blog readers receive a 10% discount off the tuition fee (promo code D10-999-FDA25 ). s John W.M. Claud will be speaking at the conference in a session titled “Crafting Your Safety Blueprint for Adverse Events and Recalls under MoCRA.” You can register for the conference here.
Lenz, Principal Medical Device Regulation Expert — FDA recently released a new eSTAR template for device pre-submissions and 513(g) Requests for Information, referred to as PreSTAR. A pre-submission provides the submitter an opportunity to obtain FDA feedback prior to a planned medical device premarket submission.
2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). Much of the guidance repeats the law and FDA’s previous notices (see e.g., our blog posts here and here ). FDA is authorized to charge an annual facility fee for OTC monograph drug facilities.
Food and Drug Administration (FDA) issued two guidance documents, one draft and one final, on food allergen labeling requirements. In addition to providing additional examples of tree nuts, the draft guidance states that FDA considers the following categories of fish to be major food allergens under Section 201(qq): Jawless fish (e.g.,
However, FDA recognizes that some “technical and operational issues,” including those involving downstream trading partners and other “affected stakeholders,” may not be fully resolved by the deadline. So what is FDA going to do? By Karla L. Drug manufacturers have had electronic systems in place since 2017. Guidance at 4.
The Washington Nationals won the World Series, Presidential administrations have come and gone, and FDA has added new meeting types and formats to its menu. And so, FDA has issued a new draft guidance to bring everyone up to speed on formal meetings under PDUFA. Tobolowsky — Much has changed since the long-gone days of 2017.
Livornese — FDA issued a Federal Register notice on September 13, 2024, seeking feedback on the Integrated Review format that the Center for Drug Evaluation and Research (CDER) began using as part of its New Drugs Regulatory Program (NDRP) modernization effort several years ago. By Deborah L. 89 FR 74966 at 74968 (Sept.
Manufacturers who submit reports via the FDA Electronic Submissions Gateway are being advised to update their systems by this time. Background FDA first introduced the final rule and guidance on eMDR in 2014 , which we blogged about here. Either way, the information is transmitted to FDA via the ESG. b)(1)(iii).
As readers of our blog know, MoCRA was a significant change to regulation of cosmetics. Now in the second year of implementation, companies have started noticing the consequences as FDA implements the new requirements and develops regulations and guidance.
Food and Drug Administration – labeled an “Official Action Indicated” classification – is generally devastating for the facility, not least because it can stall FDA approval of applications to market drugs manufactured at the facility. And the Guidance may be used as leverage to secure action from FDA on a meeting request.
Such codes need to be placed on device labels and packages to allow devices to be easily identified and tracked throughout their lifecycle, except where the rule provided for an exception or alternative. The compliance dates were first published in 2013, and subsequently updated in various guidance documents and regulations published by FDA.
Koblitz — FDA uses its Product Specific Guidance documents (“PSGs”) to provide recommendations as to the bioequivalence testing necessary for approval of a generic drug. Applicants should submit a request for a PSG teleconference within 60 days after publication of the new or revised PSG so that FDA can provide timely feedback to applicants.
Effect on FDA approvals— In cases where a biological product or drug needs to change aspects of its manufacturing processes to avoid using a covered equipment or service, will it need to file supplements with FDA for the CMC update?
By Riëtte van Laack — On September 28, 2022, FDA announced the availability of the proposed rule for the implied nutrient content claim “healthy.” The term healthy, as an implied nutrient claim, was first defined by FDA in 1994. FDA also announced it would be re-evaluating the regulatory criteria for use of the “healthy” claim.
Brevig, Senior Regulatory Device and Biologics Exper — FDA recently published Alternative or Streamlined Mechanisms for Complying with the Current Good Manufacturing Practice Requirements for Combination Products; List under the 21st Century Cures Act in the Federal Register (FR Notice). FDA must also review the list periodically.
iSpeak Blog. The patient-centric strategy further explores how demographics and epidemiology of the disease state can be impacted by using an intelligent packaging design, the adoption of decentralized clinical trial designs, and the integration of underserved communities. The Next Horizon for Therapy Innovations. Trudy Patterson.
In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.
FDA-2023-P-0313 and FDA-2023-P-0344 ) regarding its product Hetlioz (tasimelteon). Vanda requested that FDA revoke the approval of Apotex’s and Teva’s generic versions of Hetlioz on the grounds that the generic tasimelteon products did not meet the statutory “same labeling” requirement for generic drugs found in 21 U.S.C. §
Kirschenbaum — On Friday, November 4, CMS finalized a rule to implement mandatory rebates (called “refunds”) for discarded amounts of separately paid Medicare Part B single-source drugs packaged in single-dose or single-use containers. The requirement to use a JW modifier for discarded amounts beginning on January 1, 2023 remains in place.
Koblitz — Back in late September 2023 (and corrected in October), FDA issued its first interchangeable exclusivity determination pursuant to the Biologics Price Competition and Innovation Act (“BPCIA”). Notably, the purpose of the statute seemed to govern much of FDA’s interpretation.
There are common, though preventable, pitfalls that applicants may encounter, including incomplete or inadequate nonclinical data, which can be addressed by ensuring that the package of nonclinical studies submitted in the application adhere to applicable ICH and FDA guidelines.
Here I share some of the latest news, articles, editorials, or blog posts that fall generally under the theme of Pharma or healthcare. ” FDA. I might throw in a something off-topic from time to time which I found while wandering throughout the endless hallways and corridors of the internet.
Lewis, Senior Regulatory Device & Biologics Expert — On October 20, 2023, FDA announced the availability of the final guidance authored by CBER titled “Voluntary Consensus Standards Recognition Program for Regenerative Medicine Therapies.” Existing published VCS may be identified internally by FDA or externally by stakeholders.
In this blog post, we will explore best practices for pharmaceutical companies to navigate the complex landscape of regulatory challenges in marketing. Adhere to Labeling and Packaging Requirements The labeling and packaging of pharmaceutical products are tightly regulated to ensure safety and accurate information.
By Riëtte van Laack — FDA regulates pet food similar to other animal foods. Moreover, ingredients used in pet food must be approved by FDA, affirmed or listed as Generally Recognized as Safe (GRAS) by FDA, or go through the AAFCO definition process.
The statute itself – the National Bioengineered Food Disclosure Standard – requires use of one of three forms of disclosure: on-package text, a symbol, or an electronic or digital link.
Some of the GLP-1, namely Trulicity®, Mounjaro®, Zepbound®, Feisumei®, Rybelsus®, Ozempic®, Wegovy® were approved for the treatment of various target indication, by the US FDA and the EMA. per package in the US. According to Novo Nordisk , the list price of Wegovy for patients who do not have any insurance is $1349.02
Additionally, the fill finish manufacturing of biologics is a critical step in the production of biopharmaceuticals as it requires well-equipped facilities with adequate sterile filling and packaging lines to ensure sterility of the product while filling into the final containers.
The implantable neurostimulation systems usually contain sophisticated electronics, such as stimulating leads, internalized pulse generator, and electrode extenders to subcutaneously connect the leads to pulse generator which is packaged within a hermetically sealed titanium case.
Richardson — On February 15, 2023, the Nonprescription Drugs Advisory Committee (NDAC) and the Anesthetic and Analgesic Drug Products Advisory Committee (AADPAC) held a joint meeting to discuss an application pending before FDA that would switch Narcan (naloxone) Nasal Spray from prescription to over-the-counter (OTC) status.
Food and Drug Administration (FDA), requested withdrawal and destruction of all romaine lettuce on the market because the agency was unable at the time to tie the outbreak to a specific grower or region. All records required under the final rule must be made available to FDA within 24 hours after a request is made. coli contamination.
Enter the FDA’s Center for Veterinary Medicine (“CVM”). A longstanding component of the FDA and its predecessor, CVM, in its initial form as part of the Department of Health, Education, and Welfare, was established in 1965 and evolved in CVM by 1984.
We organize all of the trending information in your field so you don't have to. Join 5,000+ users and stay up to date on the latest articles your peers are reading.
You know about us, now we want to get to know you!
Let's personalize your content
Let's get even more personalized
We recognize your account from another site in our network, please click 'Send Email' below to continue with verifying your account and setting a password.
Let's personalize your content