- Sustainability
- DE&I
- Pandemic
- Finance
- Legal
- Technology
- Regulatory
- Global
- Pricing
- Strategy
- R&D/Clinical Trials
- Opinion
- Executive Roundtable
- Sales & Marketing
- Executive Profiles
- Leadership
- Market Access
- Patient Engagement
- Supply Chain
- Industry Trends
Pharma's Social Media Struggles Continue
FDA has been rolling out new guidelines for using interactive media in recent months. The new guidances clarify some murky areas, but may not make online communications any easier.
FDA has been rolling out new guidelines for using interactive media in recent months. The new guidances clarify some murky areas, but may not make online communications any easier.
FDA’s Office of Prescription Drug Promotion (OPDP) provides some useful advice in its new advisories, which were discussed further in an OPDP webinar July 10. Overall, the agency sticks to its rules requiring ads and promotional messages to be accurate, not misleading, balanced, and limited to approved uses. Because it’s very hard to get full risk information into a 140-character tweet or search engine listing, such communiqués may not fit FDA’s regulatory scheme for drugs and medical products, according to a draft guidance on using the Internet and social media platforms with character space limitations. There’s no leeway to use icons to indicate that all drugs are risky, as proposed by industry; without equal presentation of risks and benefits in a character-limited message, OPDP advises marketers to “reconsider using that platform,” especially for products with complex indications or serious risks.
Read the full version of this article here.
Johnson & Johnson Seeks FDA Approval for Subcutaneous Tremfya Regimen for Ulcerative Colitis
November 22nd 2024Johnson & Johnson has submitted a supplemental Biologics License Application to the FDA for a subcutaneous induction regimen of Tremfya for adults with moderately to severely active ulcerative colitis based on positive Phase III ASTRO trial results.
Key Findings of the NIAGARA and HIMALAYA Trials
November 8th 2024In this episode of the Pharmaceutical Executive podcast, Shubh Goel, head of immuno-oncology, gastrointestinal tumors, US oncology business unit, AstraZeneca, discusses the findings of the NIAGARA trial in bladder cancer and the significance of the five-year overall survival data from the HIMALAYA trial, particularly the long-term efficacy of the STRIDE regimen for unresectable liver cancer.
Fake Weight Loss Drugs: Growing Threat to Consumer Health
October 25th 2024In this episode of the Pharmaceutical Executive podcast, UpScriptHealth's Peter Ax, Founder and CEO, and George Jones, Chief Operations Officer, discuss the issue of counterfeit weight loss drugs, the potential health risks associated with them, increasing access to legitimate weight loss medications and more.
