Social Media Ideas for Drug Establishment Registration

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...

FDA Proposes Long-Awaited Rule to Require Foreign Tobacco Manufacturers to Register Establishments and List Products

On June 26, 2026, the U.S. Food and Drug Administration (FDA), Center for Tobacco Products (CTP), announced a proposed rule titled “Establishment Registration and Product Listing f...

FDA Issues Proposal to Streamline Registration for Advanced Distributed Manufacturers

Distributed manufacturing establishments operate a hub-and-spoke model, with a central quality oversight hub and multiple equivalent manufacturing units at different locations. Reg...

FDA Advises Businesses to Protect Their Food Facility Registration Information

One Noncompliant Healthcare System Is Remediating its Controlled Substance Deficiencies

By Larry K. Houck —

Comments on CDSCO’s Brand Name Extension Policies

Earlier this month, we had shared the news of CDSCO inviting comments on the long standing problem of Brand Name Extensions (BNE) practices. While this problem is one with severe c...

Brand Name Extensions by Pharma May Finally Be Receiving Scrutiny? 

On July 6, the Directorate General of Health Services, Central Drugs Standard Control Organization (CDSCO), published a notice inviting comments on the use of brand name extensions...

<![CDATA[DSCSA Serialization Checklist]]>

<![CDATA[DSCSA Compliance Guide: What to do now that enforcement as begun]]>

Client Alert- Ohio Board of Pharmacy Extends Reporting Deadline for Theft or Significant Loss of Prescription Drugs

Effective August 8, 2026, Terminal Distributor of Dangerous Drugs (TDDD) licensees will have 45 days following the discovery of theft or significant loss of controlled and/or non-c...

FDA Announces FY 2027 User Fee Rates for VQIP and TTP

Today FDA announced fiscal year 2027 user fee rates for importers approved to participate in the Voluntary Qualified Importer Program (VQIP) and for accreditation and certification...

Proposition 65: California Attorney General Stipulates to Judgment Prohibiting Warning Requirements for DEA

<![CDATA[Pharmaceutical Executive Daily: FDA Issues CRL to Elevar Therapeutics]]>

PEPTIDE-L WAVE! PCAC Approves Four Bulk Drug Substances for the 503A List

By Karla L. Palmer & Charles D. Snow & Mary Bass —

<![CDATA[GS1-certified traceability for DSCSA-ready supply chains]]>

Food license applicants urged to use online system directly

The Maharashtra Food and Drug Administration FDA has urged Food Business Operators FBOs and other applicants seeking food licenses in the state to apply directly through the author...

<![CDATA[Implementing a scalable pharmaceutical serialization system]]>

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

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Subcutaneous Formulation of Leqembi Iqlik]]>

DEA Has Published the Evidence Against Marijuana Rescheduling

As Judge Derek Julius prepares his recommendation and Dr. Heidi Overton awaits Senate confirmation, the federal government's own findings expose the contradiction between the AG's...

<![CDATA[What GS1 Certification Means for DSCSA (and why it matters)]]>

<![CDATA[Pharmaceutical Executive Daily: FDA Approves Ennumo]]>

CVS Caremark reaches settlement with FTC over insulin suit

Terms of the deal announced Tuesday are very similar to those the FTC reached with Express Scripts earlier this year, including requiring the PBM to stop preferring higher cost ver...

India to launch end-to-end digital drug regulatory platform in 18 months: DCGI Raghuvanshi

CDSCO is piloting Artificial Intelligence across regulatory processes to create a faster and more data-driven regulatory system