Companies must maintain thorough records to meet FDA inspection requirements, including safety substantiation files, labeling proofs, ingredient documentation, and adverse event logs. Adverse event logs must be retained for six years (three for small businesses), while registration and product listing records require annual updates. Organized, accessible, and up-to-date records are essential not only for compliance but also for growth, due diligence, and investor confidence. Compliance is a s...

Dr Tom Russ narrates his blog written for Dementia Researcher.In this guest blog, Tom traces his path into clinical research, crediting the people who guided, inspired, and challenged him along the way. From his early days in psychiatry to leading national dementia research initiatives, he explores the lessons learned from mentors like Professor John Starr and others who shaped his academic and clinical outlook. The piece underscores the importance of supportive working cultures, mentorship, and

This week’s tHEORetically Speaking News Roundup covers Evotec and Bristol Myers Squibb’s progress in developing next-generation therapies for neurodegenerative diseases, the FDA’s game-changing move to streamline biosimilar approvals and lower drug costs, and Novo Nordisk’s bold $6.5B counteroffer to outbid Pfizer for Metsera in the obesity treatment race. Tune in for this concise recap of the top stories shaping HEOR, RWE, and Market Access this week.

Under the Modernization of Cosmetics Regulation Act (MoCRA), reporting serious adverse events to the FDA is now mandatory. Companies must report serious incidents—such as hospitalizations, infections, disfigurement, or medically treated allergic reactions—within 15 business days. They must also maintain records of all adverse events for six years (or three years for small businesses). Practically, this requires setting up a system to capture and assess customer complaints, determine seriousne...

In today’s Pharmaceutical Executive Daily, we cover Novo Nordisk’s unsolicited proposal to acquire Metsera, renewed legal action against Tylenol’s manufacturer following statements from Robert F. Kennedy Jr., and AbbVie’s stronger 2025 profit outlook driven by immunology demand.

In today’s Pharmaceutical Executive Daily, we cover Thermo Fisher’s $8 billion agreement to acquire Clario Holdings, Eli Lilly’s partnership with Walmart to launch retail pickup for its direct-to-consumer Zepbound program, and the FDA’s new draft guidance aimed at streamlining biosimilar development.

In today’s Pharmaceutical Executive Daily, we cover Eli Lilly’s partnership with NVIDIA to develop an AI supercomputer for drug discovery, a surge in biotech funding rounds and public offerings, and the FDA approval of Merck’s Winrevair for pulmonary arterial hypertension.

Darshan Kulkarni highlights that to stay compliant with the FDA, companies don’t need an exhaustive set of SOPs—just the essential ones. Inspectors primarily focus on SOPs covering informed consent, adverse event reporting, drug/device accountability, source documentation, PI oversight, protocol deviations, and record retention. He emphasizes keeping SOPs concise, practical, and enforceable, training staff consistently, and expanding them only as operational needs grow. Support the show

In today’s Pharmaceutical Executive Daily, we cover the resignation of Organon CEO Kevin Ali following an internal investigation tied to Nexplanon sales, GSK’s $357 million agreement with Syndivia to expand its antibody-drug conjugate portfolio, and new guidance from the American College of Surgeons classifying obesity as a treatable condition.

Get a look at the latest September/October issue of MEDSURG Nursing! For over 30 years, MEDSURG Nursing has been the trusted resource for advancing evidence-based practice, clinical research, and professional development in medical-surgical nursing.With 3.8 NCPD contact hours available, this issue is packed with opportunities to advance your practice and deliver exceptional care. Visit www.medsurgnursing.net to subscribe or access individual articles. Don’t forget to follow us on social media for

In today’s Pharmaceutical Executive Daily, we cover the FDA approval of Bayer’s Lynkuet for menopausal hot flashes, new research suggesting Ozempic may reduce biological age, and Novartis’ $12 billion merger agreement to acquire Avidity Biosciences.

This week’s tHEORetically Speaking News Roundup covers Astellas Pharma’s Phase 4 findings showing fezolinetant’s real-world benefits for menopausal symptom relief, improved sleep, and daily functioning. We also dive into Takeda’s $11 billion collaboration with Innovent Biologics to advance next-generation cancer therapies and expand its global oncology pipeline. Tune in for this concise recap of these pivotal industry updates!

Aaron Cohen, Head of Research Oncology, Clinical Data for Flatiron Health, sits down with Amar Drawid to discuss Flatiron’s use of large language models to extract and analyze unstructured data from electronic health records. Cohen discusses how AI‑extracted data can replicate human‑curated outcomes across multiple cancer types, paving the way for faster, richer insights to guide both clinical decision‑making and drug development.