Regulatory Oversight and Compliance

The European Commission has published a strategy that will form the basis for the European Union’s policy on pharmaceuticals in the environment.

The agency published guidance on how to determine the placement and content of pediatric information in the labeling of drugs and biologics.

The agency has published a Q&A document to answer questions about what EMA is doing to prevent medicine shortages during Brexit.

The guidance provides industry with information on the design and implementation of natural history studies to support the development of treatments for rare diseases.

EMA has issued advice to healthcare professionals and patients on the potential increased risk of blood clots in the lungs and death with higher than recommended doses of Xeljanz (tofacitinib) in the treatment of rheumatoid arthritis (RA).

The guidance provides nonclinical and clinical recommendations to sponsors for the development of products for the prevention of HIV-1 infection.

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 CHMP has recommended for authorization a new medicine for patients aged 16 years and older with phenylketonuria-Palynziq (pegvaliase).

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

Orion Corporation and Bayer have announced the submission of a marketing authorization application to the EMA for darolutamide for the treatment of patients with non-metastatic castration-resistant prostate cancer.

OSE Immunotherapeutics has been granted authorization to commence a Phase I clinical trial for checkpoint inhibitor BI 765063 (previously OSE-172).

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.

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?

The European generics and biosimilars sector is working on the creation of a single pathway to accelerate development of and access to medicines.

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

Aclaris Therapeutics has been granted a marketing approval from the Swedish Medical Products Agency for ESKATA.