Social Media Ideas for Regulatory Affairs

Regulatory Affairs and Pharmacovigilance in UK

UK Regulatory Affairs and Pharmacovigilance: A Practical Guide to Compliance, Market Access and Product Lifecycle ManagementThe UK regulatory environment continues to evolve, creat...

Regulatory Affairs and Pharmacovigilance in India

Regulatory Affairs and Pharmacovigilance in India: A Lifecycle Approach for Pharma & Medical Device CompaniesIndia is a major pharmaceutical and medical device market, but succ...

Regulatory Affairs and Pharmacovigilance in Canada

Regulatory Affairs and Pharmacovigilance in Canada: A Lifecycle Approach for Pharma and Medical Device CompaniesIntroductionFor pharmaceutical and medical device companies entering...

Regulatory operations: The overlooked half of submission readiness

Submission readiness extends beyond content. Early regulatory operations planning supports a compliant, high-quality application.

2026 Regulatory Agenda Released – Updates Information Regarding GRAS Rulemaking

<![CDATA[How Companies can be Well-Prepared for Regulatory Inspection]]>

Navigating the Regulatory Labyrinth: How Biotech Leaders Are Rethinking Strategy in an Uncertain Regulatory Era

The companies that emerge from this evolving regulatory cycle with clean, rigorous, globally positioned programs will find themselves in a structurally superior competitive positio...

Regulatory Updates: GRAS Proposed Rule Clears OMB Review; FDA Sends UPF Whitepaper to OIRA

Two topics of increasing regulatory scrutiny—the "Generally Recognized as Safe" (GRAS) rule and a federal definition of ultra-processed food (UPFs)—have seen some movement at the U...

FDAQRC Strengthens Position as Premier Global Regulatory Compliance Expert with Compliance Architects Acquisition

FDAQRC has acquired Compliance Architects LLC, adding new depth to its role as a resource for pharmaceutical and medical device companies searching for global regulatory compliance...

Regulation: MAA regulatory notices (RN)

RNs will be issued by the MAA to notify changes in MAA owned process, or provide operational or engineering guidance.

From Static Content to Living Compliance: The Next Era of Regulated Content in Life Sciences

Every week, commercial and medical affairs teams face an agonizing reality: millions of dollars and hundreds of hours are spent creating regulated content, only for it to stall in...

U.S. FDA Leadership from Three Centers and OII Headline the Center Office Updates Session of the 2026 PDA/FDA Joint Regu...

PDA announced today that senior leaders from the FDA's centers for drugs, biologics and veterinary medicine as well as the Office of Inspections and Investigations will participate...

Medical Device Regulatory Expert — Hyman, Phelps & McNamara, P.C. (Washington, D.C.)

Hyman, Phelps & McNamara, P.C., the nation’s premier law firm dedicated exclusively to FDA and healthcare regulatory law, is seeking an experienced Medical Device Regulatory Ex...

REJIMUS Expands In 21 CFR Part 11 Software Validation Services for CPG Supply Chains

REJIMUS empowers FDA-regulated businesses throughout the GPG supply-chain to more quickly audit, validate, document and maintain electronic systems - including AI-enabled workflows...

Regulation: Withdrawn MAA regulatory instructions (RI)

RIs will be issued by the MAA to provide direction, and have the same authority as MAA regulation.

Enhanced FDA-SEC Collaboration: How Life Sciences Companies Think About Disclosure, Insider Trading, and Prediction Mark...

Regulating a Moving Target – FDA Seeks Comments on Possible Framework for Regulation of GenAI

By Adrienne R. Lenz, Principal Medical Device Regulation Expert —

FDA and SEC Compare Notes: What the New MOU Means for FDA-Regulated Public Companies

By Sarah Wicks & Deborah L. Livornese & Michelle L. Butler —

<![CDATA[How Regulators and the Industry Can Work Together to Improve the US Pharma Ecosystem ]]>

FDA Proposes Distributed Manufacturing Registration Pathway and Aligns Foreign Establishment Registration and Listing Re...

The U.S. Food and Drug Administration (“FDA”) issued a proposed rule to update drug establishment registration and listing requirements for distributed manufacturing (“DM”) and cer...

Midtier Life Sciences Companies Need to Rethink Their Regulatory Technology Strategy

Midtier Life Sciences Companies Need to Rethink Their Regulatory Technology Strategy The hidden cost of complexity and customization Qual...

HHS Proposes Reforms to the “Generally Recognized As Safe” Pathway

On August 10, 2026, Department of Health and Human Services (HHS) Secretary Robert Kennedy made two major announcements related to the...

Mid-Year Updates in the Pharmaceutical and Healthcare Industry

No More GRAS Self-Affirmations? FDA Proposes Mandatory GRAS Notifications