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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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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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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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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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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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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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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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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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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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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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.

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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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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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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).

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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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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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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.

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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.

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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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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.

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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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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?

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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?

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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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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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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.

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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.

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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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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.

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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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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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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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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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Pharmaceutical Technology

MAY 3, 2023

With this recent news, San Francisco-based Tenaya is initiating a multi-centre, open-label Phase Ib clinical trial for the drug. 2021 was a year of continued innovation and change in the Biopharmaceutical industry. In January 2023, Tenaya announced FDA clearance for its Investigational New Drug (IND) application for TN-201.

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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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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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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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