FDA-Approved Labeling: Is Enough Enough?
The FDA Law Blog
AUGUST 21, 2023
Livornese — I saw the sign…and the answer is no—FDA-approved labeling apparently is not enough under state failure-to-warn laws, according to certain courts.
COVID At-Home Antigen Tests: If at First You Don’t Succeed Try, Try and Try Again
The FDA Law Blog
AUGUST 23, 2022
Ironically, a recent FDA safety communication points to a potential way out of this dilemma. In this safety communication, FDA advises the public as follows: If you test negative and have COVID-19 symptoms , you test again 48 hours later for a total of two tests.
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Prescribing shift for Pfizer’s Paxlovid expands access but draws questions
Pharmaceutical Technology
JULY 20, 2022
Ganio says that, ideally, once an individual receives a positive Covid-19 result, they should call their pharmacy or communicate through a drive-through facility to minimize the risk of exposure. billion in global sales after its launch in late 2021 in the US and other countries, as per the company’s Q1 results. How to get Paxlovid.
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Are Predetermined Change Control Plans on the road to Global Harmonization?
The FDA Law Blog
NOVEMBER 29, 2023
Considerations include transparency regarding the data used to develop the change, comprehensive testing of the change, characterizing the performance of the device before and after the change, and plans in place for ongoing monitoring of device performance and communication of any unexpected changes in performance.
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Disrupted medical conferences: Lessons learnt
pharmaphorum
MARCH 15, 2022
Towards the conclusion of 2021 many societies announced another shift in format; 2022 conferences would be hybrid, or increasingly and more realistically described as ‘physical with virtual participation options,’ or similar. This article summarises the most important lessons learnt during 2020 – 2021. Lessons learnt 2020-2021.
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Eliquis interactions to avoid
The Checkup by Singlecare
JANUARY 18, 2024
Hence, it is important to communicate openly with your healthcare providers about all medications, vitamins, and supplements you take to ensure proper medical advice and monitoring. Eliquis and grapefruit Grapefruit and grapefruit juice interact with the effectiveness of many medicines due to binding to the enzyme CYP3A4.
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Aduhelm approval controversy dials up as FDA seeks probe
pharmaphorum
JULY 11, 2021
The acting FDA commissioner has sent a letter to the Department of Health and Human Services (HHS) inspector general Christi Grimm on Friday, asking for a review of the communications between the FDA and the company and the process that led to the approval of Aduhelm (aducanumab). — Dr. Janet Woodcock (@DrWoodcockFDA) July 9, 2021.
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Mastering Responses to FDA 510(k) AI Letters: A Strategic Approach
The FDA Law Blog
JULY 10, 2023
FDA communicates via a Substantive Interaction to inform the submitter either that FDA will proceed with Interactive Review or that the 510(k) will be placed on hold until FDA receives a complete response to an Additional Information request. For labeling documents and the 510(k) summary, FDA often requests both clean and redlined versions.
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Challenges & Opportunities in Emerging Digital Health Technologies
ISPE
OCTOBER 27, 2022
In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Is the software performing an action on data different from storage, archival, communication, or simple search?
Challenges & Opportunities in Emerging Digital Health Technologies
ISPE
OCTOBER 27, 2022
In December 2021, the US FDA issued a cross-center draft guidance with recommendations on the use of digital health technology tools (DHTTs) to acquire data remotely from participants in clinical investigations for medical products. Is the software performing an action on data different from storage, archival, communication, or simple search?
Cyberbullying statistics 2022
The Checkup by Singlecare
DECEMBER 15, 2022
Cyberbullying Research Center , 2021). Ditch the Label , 2017). Ditch the Label , 2017). A survey by Ditch the Label looked into young people in the UK who reported cyberbullying and the effects on their mental health. It’s best for parents to properly monitor their children’s internet communications.”.
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Welcome to SRP-RMT – Standardization Comes to Regenerative Medicine Therapies?
The FDA Law Blog
NOVEMBER 2, 2023
The absence of standards was a focal point of the Cellular, Tissue and Gene Therapies Advisory Committee Meeting in September 2021 that was convened to discuss the toxicity risks of AAV vector-based gene therapy products.
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Sulfamethoxazole-trimethoprim interactions to avoid
The Checkup by Singlecare
JANUARY 9, 2024
Avoiding them comes down to direct communication with your healthcare providers. How to minimize sulfamethoxazole-trimethoprim interactions From disease states and alcohol to a variety of medications, SMX-TMP has a diverse assortment of interactions.
OPDP Comes out Swinging With A Warning Letter on Unsubstantiated Efficacy
The FDA Law Blog
AUGUST 16, 2023
Prior to the CytoDyn letter in 2022, OPDP issued a Warning Letter in 2021 to CooperSurgical for a DTC video entitled “Paragard: Family Planning During the Pandemic” which failed to communicate ANY risk information. This seems to suggest that FDA expects this type of outcome claim to be included in labeling.
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Paving the way for anti-Abeta active immunotherapy
European Pharmaceutical Review
SEPTEMBER 22, 2023
Yves joined AC Immune in 2020 and is now Manager, Investor Relations and Communications. In 2021, she was awarded the first SEF.WomenAward for CEO of the Year by the Swiss Economic Forum. Lecanemab (BAN2401) infusion reactions and immunogenicity: results from randomized phase 2 study and an open-label extension. Wang CY, et al.
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ChatGPT, BARD, and Other Large Language Models Meet Regulated Pharma
ISPE
JULY 10, 2023
In sections where we applied ChatGPT for example cases, we indicate this as such: The question or remark from us is labeled as Authors. This so-called zero-shot approach has the strong advantage that no data must be labeled for the tailoring step and that the same model can be used for many different NLP applications.
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Sustainable pharma packaging: breaking down the barriers to adoption
European Pharmaceutical Review
OCTOBER 5, 2022
And beyond the physical limitations, those instigating industry-wide change also face pushback in the boardroom, with a recent study citing poor communication between stakeholders and rigid practices among the key barriers to more circular product packaging. Consultancy.uk; 2021 [cited 2022Sep]. 2021 [cited 2022Sep]. References.
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Metronidazole interactions to avoid
The Checkup by Singlecare
DECEMBER 6, 2023
Check food labels for inclusion of propylene glycol while on a course of metronidazole. Communicate directly with a healthcare professional anytime you require metronidazole so that a comprehensive review of interactions—of both medications, diet, and conditions—can occur to ensure a proper monitoring plan is put in place.
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Fluconazole interactions to avoid
The Checkup by Singlecare
FEBRUARY 6, 2024
The product labeling for methadone strongly advises exploring alternative options instead of using a combination of these two medications. Breastfeeding women prescribed fluconazole should openly communicate the risks and benefits, or possible alternatives, with their medical provider.
Pharmacogenetics: What pharmacists need to know
Hospital Pharmacy Europe
FEBRUARY 22, 2024
Their training and skills enable them to interpret and communicate complex medicines-related information to patients and other health professionals. Clin Pharmacol Ther 2021 Jun;109(6):1528–37 Pirmohamed M et al. Gene 2019 Nov 15;718:144050 Clinical Pharmacogenetics Implementation Consortium. Guidelines [online] McInnes G et al.
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Does Viagra work for women?
The Checkup by Singlecare
JANUARY 23, 2024
Although it’s not officially approved for female use, some healthcare providers may prescribe it off-label for female sexual dysfunction. The FDA label for Viagra explicitly states it’s not indicated for women or children. Communicating with a partner may also help alleviate anxiety and improve intimacy. Can women take Viagra?
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Sertraline interactions to avoid
The Checkup by Singlecare
OCTOBER 30, 2023
In addition, sertraline is prescribed for several other off-label indications, including binge eating disorder and body dysmorphic disorder, even sexual dysfunction conditions like premature ejaculation. Therefore, any onset of symptoms should be managed by immediate communication with a healthcare professional.
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A history of Johnson & Johnson
pharmaphorum
FEBRUARY 26, 2021
Robert Wood’s granddaughter, Mary Lea, was the first baby to be used on the baby powder label. J&J’s size meant that it had the resources to bring to bear against COVID-19 as the pandemic ravaged the world in 2020 and 2021, and the company soon began work on its own vaccine in partnership with the US government.
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The Best Probiotics for Hashimoto’s
The Thyroid Pharmacist
OCTOBER 28, 2022
Dose: While the label of the product recommends taking two capsules per day, I used higher doses, building up to four capsules, three times per day. The probiotic has been so successful in inducing remission, it has been labeled as a “medical food.” Published 2021 Jul 28. Published 2021 Oct 8. thingsIlearnedthehardway).
Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy
pharmaphorum
JANUARY 8, 2021
I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The FDA issued a statement regarding dosing schedules on 4 January 2021. “We Akiko Iwasaki (@VirusesImmunity) January 1, 2021. “I Just received this email cancelling my 2nd dose of the Pfizer vaccine. pic.twitter.com/ZDtIjm1z8W.
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Resourceful or risky? The UK’s controversial COVID-19 vaccine strategy
pharmaphorum
JANUARY 8, 2021
I DID NOT consent to receive an off-label drug with NO evidence of benefit with a single dose. The NHS Confederation, which represents leaders across the organisation, told pharmaphorum the government needed to be very clear in its communications with the public about exactly what they are being asked to do and why. “We 8/n) [link].
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Root Causes of Depression and Hashimoto’s
The Thyroid Pharmacist
JANUARY 6, 2023
It breaks my heart to think about the many thyroid patients who get labeled as clinically depressed instead of being tested for thyroid antibodies, and to think of the patients who start on thyroid hormones without consideration of dosage and form, resulting in ongoing symptoms, including depression. Published 2021 May 10. 2021.662582.
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What to Keep in Your Integrative Medicine Cabinet
The Thyroid Pharmacist
OCTOBER 27, 2023
These signals create communication and function within nerves and muscles, as the electrolytes move in or out of cells. Precautions Do not take more than the recommended dose on the label. Humic extract, the main ingredient, contains fulvate, which helps the cells in our gut better communicate with each other and bacteria.
PharmaShots' Key Highlights of First Quarter 2023
PharmaShots
APRIL 3, 2023
The company is currently conducting a P-III clinical trial of JR-141 in the US, Brazil, and the EU Under the 2021 collaboration, Takeda was responsible to commercialize JR141 outside of the US incl.
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A Proposal for a Comprehensive Quality Overall Summary
ISPE
MARCH 29, 2023
Published 15 November 2021. Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.
A Proposal for a Comprehensive Quality Overall Summary
ISPE
MARCH 29, 2023
Published 15 November 2021. Challenges with the Current Module 2 Structure The US FDA published a white paper in 2018 calling for a revision to Module 2 because, “there can be a disconnect between applicants and regulators regarding the communication of quality data and its impact on the assessment.
Health Canada expands Orkambi label to include access to infants
Pharmaceutical Technology
APRIL 11, 2023
This label expansion makes Orkambi the only disease-modifying CF medication available to patients of this age in Canada. This label expansion follows a similar label change in the US in September 2022. Health Canada is granting this new label expansion based on recent results from a Phase III study.
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Can amoxicillin treat STDs?
The Checkup by Singlecare
MARCH 28, 2024
It may also be prescribed off-label to treat other bacterial infections, including certain STDs. In 2021, more than 176,000 new cases of syphilis were reported in the U.S., Openly communicate with your medical professionals: If you’re still having symptoms of an STD despite treatment, tell your healthcare provider.
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Histamine and Hashimoto’s
The Thyroid Pharmacist
OCTOBER 6, 2023
Check food labels carefully, and be extra careful if you are eating out, as it’s difficult to know all of the ingredients used in restaurants. Published 2021 Jun 29. Published 2021 Sep 15. Published 2021 Jun 29. link] Published April 8, 2021. She was fierce, fun, dedicated, and brilliant. 2018; 7(12). Intest Res.
SPuMoNI: Enhancing Pharma Data Quality through Smart Technologies
ISPE
MAY 10, 2023
Big Data Research 24 (15 May 2021): 100172. 3M explores New Label-As-A-Service Concept with Blockchain on Azure to Stop Counterfeit Pharmaceuticals.” You may unsubscribe from these ISPE communications at any time. González-Vélez, J. García-Gómez, et al. doi:10.1016/j.bdr.2020.100172 2020.100172 9 European Commission.
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FDA updates stimulant labelling requirements to reduce misuse
Pharmaceutical Technology
MAY 12, 2023
According to the FDA update, current labels for these drugs do not have up-to-date warnings about the risks of drug misuse and abuse and fail to mention that most individuals who misuse prescription stimulants source drugs from other family members or peers. 2021 was a year of continued innovation and change in the Biopharmaceutical industry.
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Environmental Sustainability in Biopharmaceutical Facility Design
ISPE
MARCH 15, 2023
query=environment Labeling and Organization There are various ways to group the many types of environmental sustainability challenges and goals. Table 2: Organization and labeling examples for environmental sustainability issues. 33 Fixtures and fittings with a WaterSense label, can achieve a 20% reduction in indoor water use.
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Regulatory Landscape for Raw Materials: CMC Considerations
ISPE
AUGUST 30, 2022
5 (September/October 2021). The original molecular weight (MW) specification for polypropylene glycol 2000 (PPG) of 1800–2200 was based on the Food Chemical Codex monograph (90%–110% of label) and not based on a scientific understanding of the process/product requirements. 2021.09.046 2021. Published 2008. Guidance for Industry.
Legal challenges put off label use of gender affirming care drugs in jeopardy
Pharmaceutical Technology
MARCH 16, 2023
Most drugs used here are prescribed off-label, and experts say pharmaceutical companies remain hesitant to conduct clinical trials studying gender-affirming care. One of the reasons why organisations, including pharma companies, do not enter this debate is because these drugs are used off label, says Horowicz.
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Dawn of a new indication: how to study drugs for aging
Pharmaceutical Technology
MARCH 6, 2023
Based on preclinical research for their impact on aging, well-known drugs like metformin and rapamycin are already being considered for off-label usage, due to their accepted safety profile and cost-effectiveness. Bellantuono worries that labeling aging as a disease indication could be “agist” and would have social implications.
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The “Medical Bypass”: new drugs to strike obesity
Pharmaceutical Technology
NOVEMBER 30, 2022
The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. weight reduction in obese individuals, as per its label. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. compared to a 5.1%
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MSD’s Keytruda use in adenocarcinoma could be limited based on biomarker
Pharmaceutical Technology
JUNE 16, 2023
Merck ( MSD ) has announced updated results with Keytruda (pembrolizumab) in the Phase III Keynote-811 trial, which opens up the possibility of changing the checkpoint inhibitor’s label in HER2-positive gastric or GEJ adenocarcinoma so it’s based on the tumour’s PD-L1 biomarker status. Please check your email to download the Report.
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The “Medical Bypass”: new drugs to strike obesity
Pharmaceutical Technology
NOVEMBER 30, 2022
The company’s weight loss drug Saxenda (liraglutide) won an approval for chronic weight management in December 2014, and Wegovy (semaglude) got the same tag in 2021. weight reduction in obese individuals, as per its label. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. compared to a 5.1%
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AstraZeneca ends Phase IV Andexxa trial after positive results
Pharmaceutical Technology
JUNE 7, 2023
AstraZeneca will now proceed with regulatory filings in the US and EU to convert to full label approval, with full results from the trial to be presented at a forthcoming medical meeting. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. Free Report How is the Biopharmaceutical industry evolving?
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