Category: Regulatory Agency

EMA/CAT/80183/2014: Guideline on the Quality, Non-Clinical and Clinical Aspects of Gene Therapy Medicinal Products (GTMP)
The EMA guideline on quality, non-clinical and clinical aspects of gene therapy medicinal products (GTMP´s) builds on earlier documentation and [...]
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Statement from FDA Commissioner Scott Gottlieb, M.D., and Janet Woodcock, M.D., director of the Center…
Millions of Americans take medication daily to control their blood pressure. We recently found that some generic versions of one [...]
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FDA Announces Voluntary Recall of Montelukast Tablets by Camber Pharmaceuticals Due to Incorrect Drug in…
The U.S. Food and Drug Administration is warning consumers and health care professionals about a voluntary recall of one lot [...]
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Product Quest Manufacturing LLC Recalls All Nasal Products and Baby Oral Gels Manufactured at Florida…
Product Quest Manufacturing (“Product Quest”) announced its voluntary recall of Lot# 173089J of CVS Health 12 Hour Sinus Relief Nasal [...]
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Camber Pharmaceuticals, Inc. Issues Voluntary Nationwide Recall of Valsartan Tablets
As a precautionary measure, Camber Pharmaceuticals, Inc. is voluntarily recalling all unexpired lots of Valsartan Tablets, USP, 40mg, 80mg, 160mg [...]
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FDA Updates on Valsartan Recalls
Update [8/2/2018] FDA continues to evaluate valsartan-containing products and has updated the list of products included in the recall and the list of products not included [...]
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RECALL: Blood Pressure Medication, Valsartan, Recalled Due to Possible Contaminants
The Food and Drug Administration has announced a voluntary recall of a widely prescribed blood pressure medication made in China, reviving fears [...]
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Definitions of Suspect Product & Illegitimate Product for Verification Obligations Under the Drug Supply Chain…
The Drug Supply Chain Security Act ( DSCSA ) amended the Federal Food, Drug, and Cosmetic Act ( FD&C Act [...]
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FDA Unique Device Identification: Direct Marking of Devices
Unique Device Identification:  Direct Marking of Devices is a guidance document issued by the FDA on 17 November 2017 to [...]
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FDA Grandfathering Policy for Packages and Homogenous Cases of Product Without a Product Identifier
On November 27, 2017, FDA issued a draft guidance to help trading partners (manufacturers, repackagers, wholesale distributors, and dispensers) understand their compliance [...]
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Amidst Fraud Concerns in China, E&C Leaders Ask FDA for Contingency Plan for U.S. Heparin…
FOR IMMEDIATE RELEASE February 2, 2018 Contact: Press Office (202) 226-4972 Amidst Fraud Concerns in China, E&C Leaders Ask FDA [...]
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Classification of Products as Drugs and Devices & Additional Product Classification Issues: Guidance for Industry…
FDA is providing final guidance on issues frequently raised in relation to Requests for Designation (RFDs) and other classification activities.  [...]
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Product Identifier Requirements Under the Drug Supply Chain Security Act – Compliance Policy.
The Drug Supply Chain Security Act (DSCSA) was signed into law on November 27, 2013. Section 202 of the DSCSA [...]
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Regulation (EU) 2017/746 of the European Parliament & Council of 4/5/17 on in vitro diagnostic…
The European regulations governing in vitro diagnostic devices have recently been updated, and enter into force on 26 May 2022 [...]
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FDA Drug Supply Chain Security Act Implementation: Identification of Suspect Product and Notification
On December 9, 2016, FDA issued guidance for industry entitled ‘‘Drug Supply Chain Security Act Implementation: Identification of Suspect Product [...]
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Guidance for Industry and FDA Staff: Current Good Manufacturing Practice Requirements for Combination Products
This guidance describes and explains the final rule on current good manufacturing practice (CGMP) requirements for combination products that FDA [...]
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