The FDA Law Blog

JUNE 27, 2023

FDA also requests a “detailed description of the allegation with any available supporting documentation.” In our experience, the more detailed the documentation that accompanies the submission, the more likely FDA will follow-up on the submission. There are drawbacks to the current communication channels: 1.)

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The FDA Law Blog

FEBRUARY 28, 2023

The general structure of our submissions, and of many others that we have seen, is to have a document for each of the twenty sections and then to refer to other files, such as labeling and test reports, as attachments. Several sections of the eSTAR templates have questions that walk through related guidance documents.

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Viseven

JULY 25, 2024

billion for the illegal marketing of four of its off-label drugs, which became one of the biggest fraud settlements in the healthcare industry. Just a small error could lead to many people adhering to compliance documentation and making the same mistake in their work. For example, Pfizer was fined $2.3

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The Checkup by Singlecare

APRIL 5, 2024

That’s because the Food and Drug Administration (FDA) has approved it for Type 2 diabetes , while weight management is technically an off-label treatment. Foxman recommends that every patient review their formulary to see how Ozempic is covered and communicate directly with their insurer for clarity on the specific requirements. “It’s

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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. When referencing documents within the AI response, cite location within the 510(k) supplement (e.g.,

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The FDA Law Blog

OCTOBER 10, 2022

Javitt — On September 28, 2022, the FDA issued the long anticipated final Clinical Decision Support Software Guidance (CDS Guidance), which replaces the revised draft guidance document from 2019. The final guidance focuses on labeling as a means to effectuate Criterion 4. software or labeling. Other medical information.

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Viseven

NOVEMBER 17, 2022

Medical affairs in Pharma are often seen as a central agency that works within a healthcare company and prioritize communication among life science organizations, medical professionals, healthcare providers, and patients. Medical affairs definition uses clinical and scientific information to communicate the efficiency of a drug.

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pharmaphorum

OCTOBER 4, 2022

The FDA explains that regardless of the complexity of the software and whether or not the software is proprietary, the output or labelling should provide HCP users with adequate background information in plain language on the input(s), algorithm logic or methods, datasets, and validation. Criteria for regulation.

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Pharmaceutical Technology

JANUARY 6, 2023

According to the legal documents , the plaintiffs accused the companies of “violating federal antitrust laws, alleging “per se” and “rule of reason” violations”. Novartis argued that the early release of Entresto generics could cause labelling inconsistencies. Please check your email to download the Report.

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The FDA Law Blog

OCTOBER 10, 2023

By Philip Won & Véronique Li, Senior Medical Device Regulation Expert — As we recently blogged , FDA released three draft guidance documents to help enhance the predictability, consistency, and transparency of the 510(k) program. One of these documents focuses on “ Evidentiary Expectations for 510(k) Implant Devices.”

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Pharmaceutical Technology

APRIL 26, 2023

The document contains detailed information on the providers and their product offerings, alongside contact details to aid your purchasing or hiring decision. Furthermore, the rising demand for sustainable packaging solutions is gradually opening a new avenue in the primary packaging market.

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ISPE

MARCH 29, 2023

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 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

Concept Paper: M4Q(R2) Common Technical Document on Quality Guideline.” 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

JULY 19, 2023

and management communication strategy. Is the vendors’ documentation complete in order to assess GxP risks and GxP compliance? In the years leading up to 2022, numerous publications were issued; networking events, webinars, and conferences were held; and regulatory panel discussions with regulators performed.

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DiversifyRx

JULY 11, 2024

To be authorized: Pharmacies should ensure they receive, maintain, and update these documents as necessary to continue ordering from their ATP and be ready to provide copies of them upon request. Identifiers All products received must contain a product identifier. What if I do not qualify for the exemption?

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The FDA Law Blog

NOVEMBER 2, 2023

CBER may still request additional information when deemed appropriate, but the stated hope is that increased use of VCS can facilitate product development by reducing the need to develop unique methods for individual products and that they will typically reduce the amount of necessary documentation “and may reduce FDA review time.”

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The FDA Law Blog

FEBRUARY 27, 2023

Comment topics suggested by DEA include the following: Whether the rule should limit the issuance of prescriptions for controlled medications to FDA-approved indications contained in the labeling for those medications. Helpful practitioner prescribing guidance is set forth in a simplified document here. Stay tuned.

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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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ISPE

MAY 10, 2023

Although the pharmaceutical industry has consistently improved manufacturing processes 3 in compliance with good manufacturing practices, 4 there are documented deviations from good practices 5 including the continued falsification of medicines. You may unsubscribe from these ISPE communications at any time. 5 (2003): 395–413.

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The FDA Law Blog

MAY 11, 2023

GSK skinny label case , the U.S. Specifically, the Government explained, “[t]he section viii pathway cannot function properly if FDA and generic manufacturers cannot rely on an NDA holder’s representations to the agency regarding which portions of the brand-name drug’s labeling teach patented methods of use.”

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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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European Pharmaceutical Review

NOVEMBER 24, 2022

These include Meditag serialised hologram labels, first introduced in 2005 and found on all registered medicines in Malaysia to help pharmacists and inspectors detect unauthorised and counterfeit product. Elsewhere, holographic labels have been deployed effectively to arrest declining sales of pharmaceuticals.

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The FDA Law Blog

JULY 7, 2024

Section IV, Additional Resources, provides links to previously-issued guidance documents and other educational materials geared to traditional device manufacturers, with no additional commentary on how to apply these requirements to the very different clinical laboratory environment.

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pharmaphorum

SEPTEMBER 15, 2020

The huge rise in the use of telemedicine services during lockdown has brought care directly to patients in their homes, while pharma’s communications with healthcare professionals (HCPs) has experienced a similar push to digital channels. The mindset that accomplished this needs to be retained,” Jeremy says. About the interviewees.

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The FDA Law Blog

JANUARY 4, 2023

Prescription drug and medical device Pre-Approval Information Exchange (PIE) now has specific legal protection allowing for sponsors to proactively communicate to payors certain information about products in development to help expedite patient access upon product approval. By Dara Katcher Levy — A win for patient access!

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ISPE

AUGUST 30, 2022

The Common Technical Document (CTD) for the Registration of Pharmaceuticals For Human Use: Quality—M4Q guidance covers the minimum requirements for submission of raw materials; however, certain regions have additional requirements. The absence of any of the listed documentation should be scientifically justified.

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The Checkup by Singlecare

MARCH 16, 2023

This includes counting, measuring, and packaging medications, as well as labeling and organizing them for distribution. “They work closely with pharmacists to ensure that medications are prepared and dispensed accurately and safely,” he says. RELATED: Ways to prevent common pharmacy errors 7.

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The Checkup by Singlecare

JUNE 12, 2025

Recommend that patients carry documentation of any required vaccines and a current list of their medications, allergies, and medical conditions. Pharmacy teams should remind patients to always travel with prescription medication in their original, labeled containers, as recommended by the Transportation Security Administration (TSA) and CDC.

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ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Wireless medical devices. Is the action for the benefit of individual patients?

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ISPE

OCTOBER 27, 2022

Wireless medical devices use wireless radio frequency communication such as wifi, Bluetooth, and cellular/mobile phone technology. Is the software performing an action on data different from storage, archival, communication, or simple search? Wireless medical devices. Is the action for the benefit of individual patients?

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The FDA Law Blog

JULY 9, 2024

Procedures for Submitting the DAP Sponsors should describe the DAP clearly and concisely, with limited cross-referencing to previously submitted documents. If FDA determines that a waiver will be issued, it may consider public communications about the decision. Would any such failure to meet DAP goals be reflected in labeling?

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The Thyroid Pharmacist

FEBRUARY 10, 2023

A few years ago, I had a few clients with documented elevations in prolactin, and I have seen that lowering prolactin levels can help with reducing thyroid antibodies. Studies have, however, documented that bromocriptine, a medication used to lower prolactin levels, can reduce flares in lupus, another autoimmune condition.

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The FDA Law Blog

FEBRUARY 5, 2025

Lenz, Principal Medical Device Regulation Expert In early January, FDA released a draft guidance document titled Artificial Intelligence-Enabled Device Software Functions: Lifecycle Management and Marketing Submission Recommendations (Draft AI Guidance). By Adrienne R. User Interface Software Description Section VI.B

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The Thyroid Pharmacist

JANUARY 20, 2023

Please consider the following and be sure to read the precautions on individual labels before you try a new herb, supplement, or blend. (In Holy Basil ( Ocimum sanctum ) The anti-inflammatory effects of holy basil (also known as tulsi) have been documented in many in vitro and in vivo studies. Exp Toxicol Pathol. Exp Toxicol Pathol.

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The FDA Law Blog

MAY 13, 2025

Section 5 of the May 12 EO states that within 30 days, HHS will communicate MFN price targets to pharmaceutical manufacturers to bring prices for patients in line with comparably developed nations. (We note our departure from more light-hearted content and absence of musical references. Please bear with us.) 62,094, 62,097 (Oct.

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