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Set Alert for Manufacturing

US FDA's Program Alignment: Where Should Form-483 Responses Go After May 15?

Now that FDA is aligning its enforcement program with its product centers on May 15, there are questions about who in the agency should receive manufacturers' 15-day responses to Form-483 inspectional observations.

Manufacturing Quality Compliance

Latest From Manufacturing

OTC Monograph User Fees Totaling $22m To $34m Floated In Senate Discussion Draft

Bulk of user fees would be raised through facility fees, under Sens. Isakson and Casey’s discussion draft, but there's little time to add the changes to FDA user fee reauthorization bills already moving in Congress.

Consumer Consumer

Manufacturing Regulatory Updates In Brief

FDA's “Wayback” archive; EMA's whistleblower policy; IPRF's drug ID plan; reprieve for DMF holders; investigational compounding; PK/PD for kids; ISPE on quality culture; PDA on quality risks.

Quality Manufacturing

Manufacturers' Data Integrity Problems Remain FDA Investigators' Focus

US FDA official warns the pharmaceutical industry that investigators will continue to look for data integrity problems during inspections, and discusses “red flags” observed in inspections.

Manufacturing Quality

FDA Aligns New Pharmaceutical Inspectorate Into Six Divisions

US FDA’s structure for its new pharmaceutical inspectorate, part of the massive reorganization of the Office of Regulatory Affairs, includes four domestic divisions, a fifth handling foreign inspections and the sixth handling program functions. New staff directory could prove valuable to pharmaceutical companies learning to interact with a very different field organization.

Compliance Manufacturing

OTC Topicals Firm's Regulatory Problems More Than Skin Deep

FDA's warning letter submitted following an October 2016 at Phillips Co.'s Millerton, Okla., facility states that the company does not appear committed to correcting the GMP, labeling and branding problems Office of Regulatory Affairs officials found.

Consumer Manufacturing

FDA Advisory Committee Votes Against Compounding Of Coated Modified Release Drugs

FDA’s Pharmacy Compounding Advisory Committee votes to place coated modified release drugs on the “difficult-to-compound” list, thus barring these drugs from being compounded in the foreseeable future. The committee agreed with FDA’s recommendations that the complex formulation and the difficulty in manufacturing them precludes them from being compounded at the current time.

Manufacturing Quality

Reducing Serialization's Impact On Capital Costs, Equipment Effectiveness

Expert shares cost-saving tips on compliance with US Drug Supply Chain Security Act's serialization mandate.

Distribution Manufacturing

Industry Needs To Be Aware of Serialization Challenges Under DSCSA

US pharmaceutical industry is warned that products “will not flow through the supply chain if the digital data is not right” under DSCSA, says official. Law’s second phase, which takes effect in November, mandates first-ever digital serialization requirements to ward off drug counterfeiting.

Manufacturing Quality

New ICH Guideline Could Hold The Key To Better Global Management Of Product Variations

The growing complexity of procedures for making post-approval changes to product dossiers at global level is proving problematic for regulators and companies alike. Andrew Deavin, director of global regulatory affairs at GSK Vaccines, spoke to the Pink Sheet’s Ian Schofield about ongoing efforts to achieve greater regulatory convergence in life cycle management processes, including a new ICH guideline that could prove a “paradigm shift” in the handling of variations.

Life Cycle Management Regulation

US Reliance On EU Drug Facility Inspections Begins In November

FDA will have completed capability assessments for eight European Union member country inspectorates by that time, with all 28 to be completed by mid-2019; EU assessment of US regulator’s inspection capabilities wraps up in July.

Manufacturing Compliance

European Commission To ‘Explain And Discuss’ Contentious GMP Guide For ATMPs

The European Commission has agreed to meet with a group representing the world's leading pharmaceutical inspectorates to discuss its concerns about the commission's proposal to relax GMP guidelines for cell and gene therapy products. Industry, hopeful that the commission is finally ready to listen, is looking to share its concerns again as well.

Manufacturing Quality

FDA GMP Warning Letters Review: Compounding Pharmacies Drew The Most Letters In 2016

More than half of last year’s 110 drug GMP warning letters went to compounding pharmacies as US FDA’s crackdown on poor aseptic practices in sterile compounding continued. The complexity surrounding GMP applicability continued to complicate the enforcement landscape in 2016 despite FDASIA distinction between traditional and outsourcing compounders, final article in our four-part series reports.

Manufacturing Quality
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