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Novo Nordisk has asked the Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make. The FDA still has to make a decision on whether to officially place semaglutide on the lists.
The brief, 20-page document, instead, focuses on AI models used to produce data that supports regulatory decision-making about the safety, effectiveness, or quality of drugs. Most of the compounds came from commonly prescribed medications including antidepressants and statins. Continue to STAT+ to read the full story…
Food and Drug Administration to bar compounding pharmacies from making copies of its blockbuster weight loss drug semaglutide, arguing that the medication is too complex for the pharmacies to safely make , STAT reports. The FDA still has to make a decision on whether to officially place semaglutide on the lists.
The medication is available in both brand-name and compounded forms, although the compounded forms are not FDA approved. Compounded semaglutide is made by special compounding pharmacies rather than pharmaceutical companies. Does insurance cover compounded semaglutide? Does insurance cover Ozempic?
Draft guidance published by the US Food and Drug Administration (FDA) in December 2023, discussed quality considerations for topical ophthalmic drug products, including key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. This document is revised from a version published in October 2023.
But documenting the differences between Zepbound and Wegovy in a rigorous way might allow Lilly to make marketing claims about Zepbound’s superior efficacy. A trade group for compounding pharmacies slammed an attempt by Novo Nordisk to convince the U.S. That, in turn, could help the company gain market share against Novo.
Claud — Last week, FDA revised one of its two guidances relating to nitrosamines, Control of Nitrosamine Impurities in Human Drugs. FDA starts by setting the limit of what it views as acceptable intake (AI) limits, so that manufacturers and applicants can know what targets they should hit. By John W.M.
The document says that public funding for the development of vaccines and treatments should be more transparent, and include provisions to ensure that any resulting products are distributed evenly around the world. The agency issued 62 warning letters and 23 import alerts related to drugs, excluding compound-related actions.
This also includes additional requirements for pharmacies that engage in sterile and complex nonsterile compounding. Specifically, the change of ownership/location documents are quite a bit different and include some new and helpful information to assist applicants wading through the very confusing and cumbersome licensing process.
The US Food and Drug Administration (FDA) has accepted Outlook Therapeutics’ Biologics License Application (BLA) filing for ONS-5010 / LYTENAVA (bevacizumab-vikg) to treat wet age-related macular degeneration (wet AMD). Outlook stated that ONS-5010 will get 12 years of regulatory exclusivity in the US if it is approved by the FDA.
Supply chain challenges are compounded by the broader global picture, such as the war in Ukraine, the great resignation, and natural disasters. That means maintaining regulatory readiness – because having cGMP compliance problems with the FDA can significantly exacerbate the problem. It can be done, of course, but it is costly.
Although Ozempic has been approved by the Food and Drug Administration (FDA) since 2017, its status as a household name is relatively recent. Weight loss is an off-label , non-FDA-approved use for Ozempic. The FDA has urged consumers to use caution when taking medication from these compound pharmacies.
According to Dr. Bonza, these requirements might include a documented diagnosis of Type 2 diabetes mellitus and confirmation with a medical test. Look into compounded options (but be careful). Some people received coverage for Type 2 diabetes, but not many for weight loss.
Mark Neuenschwander Founding Director, THRIVCoalition.org Seminal research from 1997 on IV compounding discovered that 9 percent of manually compounded sterile preparations had incorrect ingredients and/or volumes. Worst yet, 74% of all respondents were aware of at least one pharmacy compounding error in the last 12 months.
Bristol Myers Squibb (BMS) documented a 9.1% However, the FDA's approval of Lumakras for metastatic non-small cell lung cancer in May last year has a global analyst consensus sales forecast of $336m for this year, according to GlobalData’s Drugs Database. Amgen reported only a marginal 2.2% YoY revenue growth to $26.0bn last year.
The suit – filed in a Massachusetts district court – claims that Paxlovid (nirmatrelvir and ritonavir) infringes its 11,358,953 patent which covers “compounds and pharmaceutically acceptable salts which inhibit coronavirus replication activity, and methods of treating a coronavirus infection” and was awarded earlier this month.
While L-theanine itself doesn’t contain caffeine, the two psychoactive compounds sometimes occur naturally together and are marketed as a combination in supplement form. Combining the two compounds can enhance cognition, increase alertness and focus, and reduce adverse caffeine side effects. Does L-theanine have caffeine in it?
When the Food and Drug Administration (FDA) approved Mounjaro (tirzepatide) in 2022 to treat Type 2 diabetes, some people hailed the GIP and GLP-1 medication as the next great antidiabetic drug. Ozempic Like Mounjaro, Ozempic has been approved by the FDA for Type 2 diabetes but has also shown weight loss benefits. Shop around.
Food and Drug Administration ( FDA ) has not approved the drug for use in companion animals. Azithromycin ( brand name Zithromax ) is a commonly used antibiotic that treats a broad spectrum of bacterial infections in cats, including skin infections, upper respiratory tract infections , pneumonia, bronchitis, and blood infections.
Regulatory bodies such as the US Food and Drug Administration (FDA) and European Medicines Agency (EMA) place great importance on data integrity in the pharmaceutical/life science industry. Good documentation practices. Joseph S Boakai (JSB): The three current trends are as follows: Increased scrutiny by regulatory bodies.
Severe side effects in dogs taking pantoprazole have not been documented. The FDA has not approved pantoprazole for animals. Veterinarians will use human or compounded formulations of the drug. It’s more likely that the veterinarian will give dog parents a compounded formulation. Can dogs overdose on pantoprazole?
The US Food and Drug Administration (FDA) requires that manufacturers establish whether nitrosamines, including NDSRIs, could be present in active pharmaceutical ingredients (APIs) and drug products, using the “three-step mitigation strategy described in the agency’s guidance”. Process Res. 2020, 24 (12), 2915–292. Process Res. IARC Sci Publ.
Milk thistle: This flowering herb contains an active compound called silymarin that has been linked in some studies to protecting liver cells, preventing liver damage, and reducing liver-related deaths. Food & Drug Administration (FDA) like prescription drugs. Are liver supplements beneficial?
The ISPE Sub-Committee for Paperless Validation has defined ‘Paperless Validation Systems’ as Paperless solutions enable validation lifecycle deliverables to be generated, approved, and more importantly, testing to be completed without the need for the printing of paper test documents. If It Is Not Documented, It Did Not Happen.
ISPE continues to build on its mission and commitment to providing content for the industry through guidance documents and its CoPs, including expanding CoP topics. Five successful conferences drove financial performance more than expected, and guidance documents have been very strong.
Food and Drug Administration (FDA) for use in dogs. There are no azithromycin products formulated for dogs, so pet owners will rely on human formulations or customized products from a compounding pharmacy. Azithromycin is a broad-spectrum antibiotic that fights several types of bacterial infections in dogs.
The only FDA approved treatment for post-partum depression is a progesterone analogue that must be delivered over a 60-hour IV infusion and appears mildly efficacious. There have been a couple of small case series document LSD use in pregnancy and normal birth outcomes, although these are not high quality or conclusive by any means [23].
5 It includes cleaning validation master plan, product risk assessment, utility and equipment readiness, analytical method readiness, sampling site selection/grouping, standard operating procedures, validation protocols, execution of validation protocols, personnel training, and the validation documentation package.
While this is essential in the interrogation of novel compounds for which we know very little about their efficacy and safety, it is also true that some biomedical research is highly wasteful. It is estimated that only one in 10 drugs that enter Phase I trials are subsequently licensed by the US Food and Drug Administration (FDA).
Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3
Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” As part of the US Food and Drug Administration (FDA) QbD pilot 4 in 2005–2006, the need to convey how the control strategy is linked to the target product profile (TPP) and quality target product profile (QTPP) was discussed. The authors propose using Module 2.3
The document provides specific guidance on the sampling and testing procedures for environmental monitoring, as well as the limits for particular and microbial contamination. ISPE Good Practice Guide on Containment for Potent Compounds 4. Environmental monitoring is another important aspect of Annex 1.
China still hasn’t approved western mRNA vaccines, despite submission, and the US FDA rejects Chinese-only trial data for cancer medicines. For pharma, the impact in critical areas such as the performance of newly marketed innovation has already been documented. In fact, first six months sales are almost 20% lower.
I’ve seen a number of airborne toxins showing up as frequent triggers/exacerbating factors for my clients’ autoimmune conditions — mold, volatile organic compounds (VOCs), and artificial/synthetic fragrances, in particular. For cleaning products, only compounds need to be identified. Volatile Organic Compounds (VOCs) .
He warned, “Implementation of a CCS will require more than writing documents.”. This also occupies a large resource, given the US Food and Drug Administration (FDA) requirement for double plate checking using a second ‘independent’ person. The FDA is doing this through the publications of Guidance for Industry.
In the US, botanical dietary supplements can be sold without US Food and Drug Administration (FDA) approval, 1 prompting many vendors to promote the use of botanical products as dietary supplements , 2 rather than pursue a path of regulatory approval. 3 Is two too few? 3 Is two too few?
Examples include platforms as small as autonomous units placed within a facility and mobile production trailers for compounding to platforms as large as a prefabricated, self-contained GMP facility. FDA Official Warns Manufacturers of Common Problems Found in Aseptic Operations.” September 2022. 7 March 2023. Regulatory Focus.
Improvements have been observed by various regulatory agencies in Latin America for the acceptance and implementation of international standards—for instance, the ICH Common Technical Document (CTD) format. Additional required information beyond ICH guidelines, or non-value-added documents (e.g., 6, and 2.3.S.7 7 are required.
For example, an assessment for a facility primarily focused on US and EU markets would only consider GMPs and regulations from EudraLex and the FDA. FDA CFR Title 21 Parts 211, 600, and 1271; 8. , FDA Guidance for Industry: Sterile Drug Products Produced by Aseptic Processing–Current Good Manufacturing Practice, 11.
A 2015 case report documented the thyroid labs of a man who had recurrent hyperthyroid episodes after three of his wife’s pregnancies! In fact, in 2006, the Centers for Disease Control reported that the average American has 116 out of the 148 commonly tested synthetic compounds in their body. His wife had Hashimoto’s.)
With shortages, regulatory complexity is compounded due to differences in submission and data requirements from various regulatory agencies. Recent US FDA data show that the lack of raw material availability contributes to 27% of drug shortages (see Appendix ). It is considered a moderate change by the FDA (CBE30) and NMPA.
In 1998, the Food and Drug Administration (FDA) defined an adaptogen as a new kind of metabolic regulator that has been proven to help in environmental adaptation and to prevent external harms. Guduchi has many biologically active compounds viewed as having potential application in clinical research. Anc Sci Life. 2012;31(4):151–159.
In June, the US Food and Drug Administration’s (FDA) Psychopharmacologic Drugs Advisory Committee (PDAC) rejected 1 Lykos Therapeutics’ psychedelic new drug application (NDA) for midomafetamine (MDMA) capsules used alongside MDMA-assisted therapy to treat post-traumatic stress disorder (PTSD) in adults.
Published research has documented two possible dosages for feline insulin-resistant diabetes: For insulin-resistant diabetes: 50 mg daily given in two divided doses OR 2 mg/kg given every 12 hours Human formulations of metformin come in much larger dosage strengths than this. The smallest metformin tablet for people is 500 mg.
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