ISPE

MARCH 6, 2023

Secured by default When the FDA determines a manufacturer violated manufacturing practices, including ALCOA, they issue a Warning Letter. A software application must produce an audit trail to be compliant per FDA regulations (21 CFR Part 11) and EU Regulation (EU Annex 11, Section 12). Register Now!

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pharmaphorum

OCTOBER 12, 2018

The development of software applications that are available with a prescription took a major step forward last year with the first FDA approval for a mobile medical application with both a safety and efficacy label. We’ll be looking at how digital and traditional approaches to medicine are being combined to improve patient outcomes.

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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. The only schedule III-V narcotic drug that is currently approved by the FDA for OUD treatment is buprenorphine.

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Controlled Substances FDA Documentation Communication 59

The FDA Law Blog

JANUARY 22, 2024

OC and CDER continue to use a carrot-and-stick approach with compounders, noting both the creation of the Compounding Quality Center of Excellence and its collaboration with the industry, but also the eleven warning letters FDA sent to drug compounders last year. Drug Supply Chain. Clinical Trials.

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Compounding FDA Communication 59

Pharma Marketing Network

FEBRUARY 19, 2025

Regulatory-Friendly Communication : Unlike social media ads, emails offer controlled messaging that aligns with compliance regulations. Challenges in Pharma Email Marketing Pharma brands face unique barriers that other industries dont , such as: Strict compliance regulations (FDA, GDPR, HIPAA) that limit messaging. Ideal: 2-5% CTR ).

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HIPAA FDA Communication Labelling 72

Pharmaceutical Technology

NOVEMBER 30, 2022

In the first official regulatory guidance on this matter released in 2008, the Food and Drug Administration (FDA) established CCIT as a requirement, closely tying it to the concept of microbiological integrity. Free Webinar. Webinar: Why and how to replace Dye Ingress Test by deterministic CCIT methods. Wallis and Futuna.

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Packaging FDA Communication 52

Pharma Marketing Network

DECEMBER 4, 2024

Tools like telehealth platforms, mobile apps, and digital detailing enable seamless communication with HCPs and patients. Stay updated with regulations from the FDA, EMA, and other governing bodies to avoid costly penalties. Using email, social media, in-person meetings, and webinars to deliver a consistent message across platforms.

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Communication Packaging FDA 52

Viseven

AUGUST 15, 2024

For instance, the FDA’s requirement for Patient Perspectives in drug reviews has made patient engagement crucial for approvals and reimbursements. This education can be delivered through various formats, such as webinars, videos, and written materials.

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Pharmaceutical Companies Pharmaceutical Companies Communication Packaging 52

Pharma Marketing Network

JANUARY 9, 2025

Educational Content: Beyond promoting products, offer valuable resources like blogs, webinars, and infographics. Engaging on Digital Platforms: Patients are increasingly turning to online communities for advice and support. Clearly communicating the benefits and risks of drugs like Keytruda establishes credibility and trust.

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HIPAA Communication FDA 52

DiversifyRx

JULY 11, 2024

Small Dispensers and the 6/12/2024 FDA Announcement Concerning DSCSA This week’s article on the recent DSCSA postponement comes from PRS Pharmacy Services. Join our next Awesome Webinar Series with guest legal guru JD from Real Value Rx to answer any questions you have about the DSCSA delay. The DSCSA Adventure continues.

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Independent Pharmacies FDA Documentation CPhT 52

Pharma Marketing Network

JANUARY 29, 2025

A great example is how Merck and AstraZeneca use AI-driven content to engage physicians via targeted LinkedIn campaigns, automated email sequences, and interactive medical webinars. For patients, omnichannel marketing is about seamless communication. Social media and digital marketing have blurred the lines of compliance.

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FDA Communication 52

Pharma Marketing Network

JANUARY 9, 2025

Thought leadership content, webinars, and live Q&A sessions help build trust and visibility. Automation: Email marketing and CRM tools streamline communication, saving time while maintaining personalization. FDA and EMA Updates: Regularly monitor guidelines from agencies like the FDA (U.S.)

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HIPAA Process Improvement FDA Communication 52

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. For instance, FDA highlights risks associated with everyday activities (e.g.,

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FDA Documentation Labelling Communication 45

Pharma Marketing Network

OCTOBER 1, 2024

One of the primary objectives of pharma marketing is to communicate the benefits and safety profiles of medications to healthcare providers and patients. This shift allowed companies to communicate directly with patients, raising awareness about specific medical conditions and available treatments.

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Communication Pharmaceutical Companies Pharmaceutical Companies FDA 52

Omnicell

JANUARY 10, 2023

Namely, there are currently more than 400 new cell and gene therapies under development, and 60 percent of the new molecular entities awaiting FDA approval are specialty pharmaceuticals. “We need to move beyond communication and toward delivering care,” said Christopher Antypas, President of Perigon Pharmacy 360.

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Pharmaceutical Technology

MARCH 22, 2023

According to the GlobalData report Contract Injectable Packaging Trends in the Bio/Pharma Industry , more than half (55%) of FDA drug approvals in 2021 were accounted for by injectables. This on-demand webinar discusses the importance of a patient-appropriate BL & GF profile. Please check your email to download the Webinar.

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Pharma Marketing Network

FEBRUARY 5, 2025

Host webinars and thought leadership discussions to showcase expertise. Compliance Challenges and How to Overcome Them Pharma marketing on social media comes with strict regulations , including: FDA and EMA guidelines restricting direct-to-consumer advertising. Connect with key opinion leaders (KOLs) and medical influencers.

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HIPAA Communication FDA 52

Pharma Marketing Network

DECEMBER 19, 2024

Education and Training: Provide resources like webinars or white papers to engage HCPs effectively. Solution: Partner with legal and compliance teams to ensure all campaigns adhere to FDA and HIPAA guidelines. Clearly communicate data usage policies to build trust.

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HIPAA Communication FDA 52

ISPE

JULY 19, 2023

and management communication strategy. 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. ™ hackathons were established, and the ISPE Factory of the Year (FOYA) award category was created.

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Documentation FDA Communication Labelling 98

Pharmaceutical Technology

FEBRUARY 23, 2023

Fraction absorbed is directly related to the solubility, dissolution, and permeability of a compound and is the amount of drug that enters the intestinal enterocyte in our gastrointestinal tract (FDA definition), whereas bioavailability (F) is the amount of drug in the systemic circulation able to have a therapeutic effect.

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Compounding Dosage Packaging Communication 98

ISPE

NOVEMBER 22, 2022

The Summit explored situations where proper planning, coordination, and communication are achievable and asked how can Remote Interactive Evaluations/Distant Assessments (or other remote/virtual approaches) become effective tools for playing an important part in future regulatory inspections? FDA (US Food and Drug Administration).

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Communication FDA 52

ISPE

AUGUST 29, 2022

In May 2021, the US Food and Drug Administration (FDA) published a draft industry guidance, ICH Q12: Implementation Considerations for FDA-Regulated Products. The FDA has also offered both early dialogue and training to share knowledge and experience with the industry, providing an excellent example for other regulators to follow.

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Documentation FDA Communication Packaging 52

ISPE

JANUARY 10, 2023

US Food and Drug Administration webinar. 5 The FDA has indicated it may “consider available information and approaches to mitigate the risk to product quality associated with the change to support a reporting category for certain supplements that is lower than what otherwise would be most suitable.” 3 Ramanadham, M.

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Packaging FDA Communication Vaccines 52

Pharma Marketing Network

MARCH 18, 2025

Organizations like the FDA (U.S.), Combining HCP webinars, digital advertising, and interactive medical content enhances outreach effectiveness. Omnichannel marketing ensures consistent and personalized communication across digital, social, and traditional platforms, improving engagement with HCPs and patients.

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Communication Labelling FDA 52

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.

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Documentation FDA Labelling Communication 95

The FDA Law Blog

FEBRUARY 20, 2025

Despite this impending massive change in regulatory scope, the President and his Department of Government Efficiency (DOGE) fired hundreds of FDA employees this past weekend. If this happens, laboratories will not be able to anticipate what data FDA wants. The materials from this webinar are still available on FDAs website ( here ).

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