Quality Systems

The company is recalling Levoleucovorin Injection, 250 mg/25 mL because of copper salts found during stability testing.

The company is recalling 8.4% Sodium Bicarbonate Injection USP, 50 mEq/50 mL (1 mEq/mL) because of glass found in product.

The agency published guidance to help with the development of enrichment strategist for clinical investigations of drug and biologic effectiveness.

FDA sent a warning letter to Hospira Healthcare India Pvt. Ltd. for CGMP violations including data integrity issues.

Norman (Ned) Sharpless, director of the National Cancer Institute at the National Institutes of Health, will become FDA acting commissioner.

The FDA planned budget features added funds allotted to improved oversight of drugs, biologics, and medical devices.

FDA sent a warning letter to Jubilant Life Sciences after investigators found CGMP violations.

Ned Sharpless is tapped to take on acting commissioner role following Gottlieb’s resignation.

A federal court ordered Guardian Pharmacy Services to stop producing compounded drugs.

The agency prioritized the review of the generic angiotensin II receptor blocker to help relieve the shortage of valsartan due to recent recalls.

As part of FDA’s ongoing effort to modernize interactions with industry, FDA launched a portal to help with submissions of controlled correspondence via email instead of manual data entry.

The agency sent a warning letter to ANDAPharm, LLC after inspectors found the company’s cleaning and stability testing procedures were inadequate.

The new automated cloud-based tool allows for the design of targeted single-cell DNA custom panels.

FDA Commissioner Gottlieb released a statement on the agency’s efforts to refine the naming convention for biosimilars to balance competition and to help ensure patient safety.

Janssen’s Spravato (esketamine) gains approval with restricted distribution guidelines.

Hetero Labs recalls losartan potassium tablets due to presence of N-Nitroso-N-methyl-4-aminobutyric acid.

Gottlieb’s tenure included record new drug approvals and steps taken to curb opioid abuse.

The FDA commissioner plans to leave the agency in April.

FDA guidance on quality considerations for continuous manufacturing should help advance implementation by providing clarity and giving companies more confidence to make investments in the new technology.

The company is voluntarily recalling four lots of Drospirenone and Ethinyl Estradiol Tablets, USP because of the possibility they may contain defective blister packs and incorrect tablet arrangements.

Do patients get what they pay for when they demand cheaper drugs?

Understanding the API, delivery mechanism, and excipient functionality is essential to solving drug solubility challenges.

Simplification is crucial to maintain data integrity, according to Siegfried Schmitt, PhD, vice-president, technical at PAREXEL Consulting.

FDA expects more than 200 investigational new drug applications for cell and gene therapies by 2020, causing the agency to strengthen its regulatory program.

A draft guidance document provides recommendations for submitting bioavailability information in investigational new drug and new drug applications.

Macleods Pharmaceuticals Limited is voluntarily recalling one lot of Losartan Potassium/Hydrochlorothiazide combination tablets 100mg/25mg after NDEA is found in finished product manufactured with API made by Hetero Labs Limited.

In a statement, FDA Commissioner Scott Gottlieb laid out the case for the safety and effectiveness of generic drugs compared to brand drugs.

The Swiss Agency for Therapeutic Products has begun entering GMP compliance information in the European Union’s EudraGMDP database.

The USP Quality Institute’s third fellow in its Fellowship in Quality Medical Products program will study the role of poor-quality medicines in fostering antimicrobial resistance.

The agency clarified the process for development programs for regenerative medicine therapies.