FDA Proposes Front-of-Package Nutrition Label for Most Packaged Foods
Pharmacy Times
JANUARY 17, 2025
If finalized, the requirement would include readily available nutrition information, including saturated fat, sodium, and added sugar content.
STAT+: The FDA is testing new nutrition labels on the front of food packages
STAT
JUNE 20, 2023
WASHINGTON — The FDA wants to make it easier for consumers to know if the foods they’re buying are unhealthy — but doing so is harder than it seems here in the United States. Now, the Food and Drug Administration is embarking on a major study to test front of package labels here in the U.S.,
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STAT+: House committees strike deal on health transparency, PBM reform package
STAT
SEPTEMBER 6, 2023
WASHINGTON — Republicans on three key House committees have reconciled their differing legislative packages to increase transparency in the health care system and reform payment practices for both pharmacy middlemen and hospitals, according to a bill draft obtained by STAT. However, Democrats are not necessarily on board.
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STAT+: FDA introduces plan to assess safety of common chemicals added to food
STAT
SEPTEMBER 26, 2024
— Food additives rarely face FDA scrutiny once they’re on the market, even those with mounting evidence of safety concerns. The public meeting on the FDA’s campus drew dozens of food safety advocates, industry representatives, concerned citizens, and state and federal lawmakers. SILVER SPRING, Md.
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STAT+: PBMs face scrutiny from all sides, and analyzing Marty Makary’s road to the FDA
STAT
DECEMBER 17, 2024
The language of the government funding package has not been publicly released as of Monday night and could still change, but sources indicate some longtime health care policy priorities are making the cut for the year-end spending deal, Rachel Cohrs Zhang reports.
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What is compounded semaglutide made of?
The Checkup by Singlecare
JANUARY 9, 2025
Food and Drug Administration (FDA). Why and when semaglutide is compounded According to the FDA, compounded drugs are made by licensed pharmacists (or under the supervision of pharmacists in outsourcing facilities) who combine, mix, or alter ingredients of a drug. There are a few times when compounding is necessary.
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Opinion: Patients might finally receive practical information with prescriptions — if the FDA doesn’t blow it
STAT
SEPTEMBER 12, 2023
After years of deliberation, the FDA has proposed giving patients a simple one-pager for every prescription drug with the information needed for safe and effective use. The Food and Drug Administration knows many of the answers. It wants patients to know them, too.
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FDA declines Eli Lilly’s bowel disease drug over manufacturing issues
Pharmafile
APRIL 14, 2023
Pharma giant Eli Lilly’s Biologic Licence Application (BLA) for its bowel disease drug has been declined by the FDA over concerns about the proposed manufacturing of the drug. However, concerns weren’t expressed over the clinical data package, safety or label for the medicine.
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FDA Announces Delayed Enforcement of DSCSA to 2024
Pharmacy Times
AUGUST 28, 2023
The start date of the package-level electronic tracking system will shift from November 27, 2023 to November 27, 2024.
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GSK details Blenrep combo data that could bring the multiple myeloma ADC back to life
Fierce Pharma
FEBRUARY 5, 2024
If a new package of pivotal data satisfies the FDA, GSK could have another run at the U.S. | If a new package of pivotal data satisfies the FDA, GSK could have another run at the U.S. multiple myeloma market with its previously withdrawn BMCA-targeted antibody-drug conjugate, Blenrep.
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FDA issues draft guidance on alternative tools for facility assessments
European Pharmaceutical Review
OCTOBER 17, 2023
The US Food and Drug Administration (FDA) has published draft guidance on how it intends to use alternative tools for assessing drug manufacturing facilities identified in pending marketing applications. Fundamentally, this approach will establish whether facilities meet applicable requirements for FDA approval and licensure decisions.
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Rising Demand for Pharmaceutical Secondary Packaging Providers
Roots Analysis
APRIL 20, 2022
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.
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Common pharma compliance concerns cited by FDA warning letters
European Pharmaceutical Review
AUGUST 23, 2022
A study of the causes of warning letters issued by the US Food and Drug Administration (FDA)’s Center for Drug Evaluation and Research (CDER) and Center for Devices and Radiological Health (CDRH) between 2010 and 2020 revealed that poor current good manufacturing practice (cGMP) compliance and misbranding were the most common citations.
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FDA approves first ever OTC birth control pills
The Checkup by Singlecare
JULY 14, 2023
Food and Drug Administration (FDA) approved the first over-the-counter birth control pill , Opill (norgestrel), on July 13. According to the FDA, there are 3 million unintended pregnancies in the U.S. Today’s FDA decision is a historic moment for health equity, sexual health, and reproductive rights. … How does Opill work?
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FDA releases draft guidance for decentralised clinical trials
European Pharmaceutical Review
MAY 2, 2023
The US Food and Drug Administration (FDA) has released a new draft guidance to further support the use of decentralised clinical trials (DCTs) for drugs, biologics and devices. The FDA’s regulatory requirements for investigations of medical products are the same for DCTs and traditional site-based clinical trials.
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FDA guidance highlights E&L considerations for ophthalmic drug products
European Pharmaceutical Review
JANUARY 25, 2024
Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key considerations for extractables and leachables (E&L) testing. Ophthalmic drug products should be evaluated for extractables and leachables, FDA asserted.
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FDA approves over-the-counter naloxone
The Checkup by Singlecare
MARCH 31, 2023
Food and Drug Administration (FDA) approved a non-prescription version of Narcan (naloxone), a nasal spray used to rapidly reverse the effects of an opioid overdose. According to the FDA, drug overdose is a persistent public health problem in the United States. This week the U.S. chief medical officer of Toolbox Genomics.
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Opinion: FDA’s plan to define “healthy” for food packaging: Better than the existing labeling anarchy, but do we really need it?
STAT
OCTOBER 7, 2022
The FDA has announced the set of rules it proposes to enforce for manufacturers to claim that a food product is “healthy.” ” The proposed rules are a lot better than the labeling anarchy that currently exists. But here’s my bottom line: health claims are not about health. They are about selling food products.
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STAT+: Pharmalittle: We’re reading about the FDA listing Novo drugs as ‘available,’ pharma layoffs, and more
STAT
OCTOBER 31, 2024
Of course, this calls for a cup of stimulation, and we are opening a new package of pecan pie for the occasion. With all doses now listed as available, the FDA may soon pull it off the list, depending on its conversations with Novo about whether the company can sufficiently meet demand going forward. Sound familiar?
Development and Manufacturing of Primary Packaging and Medical Devices
Pharmaceutical Technology
APRIL 26, 2023
Packaging plays a critical part in the pharmaceuticals and medical devices industries and is developed with its own set of security standards for the safety of consumers. The role of primary packaging has extended beyond the primary objectives of sterility, physical and chemical protection, and security.
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Pioneering Sustainability: A Journey Through Milestones in Sustainable Packaging Industry
Roots Analysis
AUGUST 26, 2024
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.
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Listen: What makes food ‘healthy’ and why we don’t prioritize nutrition
STAT
OCTOBER 19, 2022
After years of deliberation, the FDA recently announced a new set of rules it proposes to regulate claims on food packaging that a product is “healthy.” ” The most basic rule: the product must actually contain food, not just ingredients.
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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach
The FDA Law Blog
JULY 10, 2023
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.
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STAT+: How the first over-the-counter birth control pill in the U.S. got its ‘unapologetic’ design
STAT
JULY 27, 2023
It’s not every day that a marketing team is tasked with designing the branding and packaging of the first over-the-counter birth control pill to be sold in the U.S.
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Zevra wins FDA panel backing for previously rejected arimoclomol
Pharmaceutical Technology
AUGUST 5, 2024
Reinforced with additional data, Zevra’s arimoclomol data package has gained a positive opinion in Niemann-Pick disease type C from an FDA advisory committee.
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FDA approves GSK’s Blenrep for advanced multiple myeloma
pharmaphorum
AUGUST 6, 2020
The FDA has approved GlaxoSmithKline’s multiple myeloma drug Blenrep, a first-in-class potential blockbuster that will be used in advanced disease. The post FDA approves GSK’s Blenrep for advanced multiple myeloma appeared first on. Keratopathy leading to treatment discontinuation affected 2.1% of patients in the cohort.
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STAT+: Pharmalittle: FTC suit over Amgen spotlights ‘bundling’ deals with insurers; FDA staff says Pfizer RSV vaccine is effective
STAT
MAY 17, 2023
Simply put, this occurs when a drug company combines two or more medicines in a package deal for health plans and pharmacy benefit managers, which determine lists of medicines that are covered by insurance. The FDA is slated to make a decision on whether to clear the shot in August. Continue to STAT+ to read the full story…
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Pharmacy Law and Licensing Highlights 2025
The FDA Law Blog
FEBRUARY 2, 2025
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.
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FDA Issues Long-Awaited QMSR Final Rule
The FDA Law Blog
FEBRUARY 21, 2024
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
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What FDA’s Newest Gene Therapy Approval Tells Us About Durability: How Long is Long Enough?
The FDA Law Blog
DECEMBER 7, 2022
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.
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FDA accepts BLA for Sandoz’s proposed biosimilar natalizumab
Pharmaceutical Technology
JULY 26, 2022
The US Food and Drug Administration (FDA) has accepted the biologics licence application (BLA) of Novartis subsidiary Sandoz for natalizumab, a proposed first-ever multiple sclerosis (MS) biosimilar to reference medicine Tysabri. A complete analytical, preclinical and clinical data package is part of the BLA and MAA submissions.
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Trading Partners May Exhale: FDA Releases Guidance Exercising a Year-Long Period of Enforcement Discretion Related to DSCSA Enforcement of Certain Provisions
The FDA Law Blog
AUGUST 27, 2023
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.
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STAT+: What happened to the House vote on health care price transparency?
STAT
SEPTEMBER 19, 2023
About last night… House leadership last night canceled a scheduled vote on a health care package that included transparency requirements for hospitals and insurers, reforms to some PBM practices, and a small site-neutral payment policy for administering drugs, Rachel writes.
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FDA Issues Two Guidance Documents on Food Allergen Labeling Requirements
The FDA Law Blog
DECEMBER 8, 2022
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.,
Does Mounjaro need to be refrigerated?
The Checkup by Singlecare
DECEMBER 17, 2024
Like semaglutide, Mounjaro (tirzepatide) is a once-a-week injectable medication that is FDA approved for helping manage blood sugar levels in those with Type 2 diabetes. It mimics two gastrointestinal hormones: glucagon-like peptide-1 (GLP-1) and gastric inhibitory polypeptide (GIP).
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FDA Brings its Formal Meetings Guidance Up to Date: What You Need to Know About Type D, INTERACT, and “In-Person” Meetings Under PDUFA
The FDA Law Blog
SEPTEMBER 27, 2023
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.
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STAT+: Pharmalittle: We’re reading about a Pfizer daily weight loss pill, a Novo Nordisk setback, and more
STAT
JULY 11, 2024
This calls for celebration with a cup of stimulation, and we are opening a new package of blueberry muffin for the occasion. This comes after the FDA in May convened a group of advisers to discuss the drug, called icodec. What is upon us right now, however, is our ever-growing to-do list. Sound familiar? Have a great day, everyone.
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STAT+: Pharmalittle: We’re reading about Congress punts PBM reform, another obesity drug and more
STAT
FEBRUARY 27, 2024
Hope you have a meaningful and productive day and, of course, do stay in touch… Congress has abandoned its attempt to reform how pharmacy middlemen operate in an upcoming package to fund the federal government , STAT reports. Drug makers and pharmacy benefit managers have fought a very public battle on the airwaves.
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US FDA grants orphan drug status for XORTX’s oxypurinol
Pharmaceutical Technology
APRIL 24, 2023
The US Food and Drug Administration (FDA) has granted orphan drug designation (ODD) to XORTX Therapeutics’ oxypurinol to treat autosomal dominant polycystic kidney disease (ADPKD) patients. The company noted that the ODD from the FDA is not an approval for the use of XORLO, a formulation of oxypurinol.
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FDA Draft Guidance: Everything You May Want to Know about OMUFA Fees
The FDA Law Blog
NOVEMBER 14, 2022
2022, FDA published a draft guidance on FDA’s implementation of the Over-the-Counter Monograph Drug User Fee Program (OMUFA). FDA is authorized to charge an annual facility fee for OTC monograph drug facilities. FDA will not refund any fees that have been incurred already). By Riëtte van Laack & Deborah L.
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STAT+: Patients for Affordable Drugs taps new leader
STAT
SEPTEMBER 19, 2022
Merith Basey, who most recently led a group that promotes access to medicine by pressuring universities, took the helm of Patients for Affordable Drugs as the group is fighting to defend implementation of Democrats’ major drug pricing reform package , including a brand-new Medicare drug price negotiation program.
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Kellogg’s is going to war over Mexico’s nutrition label rules. A similar fight is coming to the U.S.
STAT
AUGUST 21, 2023
Any food with a warning label — like Kellogg’s Fruit Loops or its Frosted Flakes, which typically contain more than 37 grams of added sugar in a 100-gram serving — is also banned from including a mascot on its packaging. Read the rest…
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A quick guide to transferring a commercial drug product to a new fill-finish CDMO
Pharmaceutical Technology
SEPTEMBER 4, 2024
Between 2012 and 2021, outsourcing propensity for FDA NDA injectables approvals averaged 40%, according to GlobalData’s Contract Injectable Packaging Trends…
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FDA rejects Lilly’s BLA for UC drug over manufacturing concerns
Pharmaceutical Technology
APRIL 14, 2023
The US Food and Drug Administration (FDA) has rejected Eli Lilly’s biologic licence application (BLA) for the ulcerative colitis (UC) drug mirikizumab over manufacturing concerns. No concerns related to the clinical data package, safety or the medicine label. The regulator has issued a complete response letter.
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