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September 2018

No. 314


Full Issue of Drug GMP Report in PDF Format

Download and view the full issue. Read More

FDA Issues Guidance on Controlling Elemental Impurities in Drugs

The FDA finalized its recommendations on how drug sponsors submitting applications should control elemental impurities in their drug products. Read More

FDA Finalizes Dissolution Testing Guidance for Immediate-Release Solid Oral Dosage Forms

The FDA issued final guidance on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances. Read More

TGA Calls for Comments on Boxed Warning Requirements

Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention. Read More

Warning Letter Roundup: FDA Targets Firms for Quality Failures

The FDA hit five facilities with warning letters, citing them for multiple violations, including a failure to test for conformity. Read More

483 Roundup: Three Facilities Slammed for Various Deficiencies

The FDA issued Form 483s to three companies for an array of issues, such as poor recordkeeping and inadequate employee training. Read More

FDA Found Repeat Deficiencies at Valsartan Manufacturer’s Facility

In another twist in the worldwide recall of the contaminated blood pressure medication, valsartan, the FDA released two Form 483 reports issued to the API’s manufacturer in China after inspections in 2016 and 2017. Read More

Court Overturns Ruling Finding GSK Liable for Generic User’s Suicide

In a case that centered on labeling, an appeals court overturned a federal court ruling that GlaxoSmithKline was liable for the suicide of an attorney who took a generic of its antidepressant drug Paxil (paroxetine). Read More

Westminster Recalls Thyroid Drugs Due to API Supplier’s Deficiencies

Westminster Pharmaceuticals recalled two of its thyroid drugs after manufacturing them with APIs sourced from a Chinese supplier the FDA cited for GMP violations. Read More

Senator Markey Blasts FDA’s REMS for Opioid Products

Sen. Edward Markey (D-Mass.) urged the FDA to overhaul the risk evaluation and mitigation strategy (REMS) program. Read More