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.

Uncertainty remains around the UK’s departure from the EU, potentially causing irreparable damage to the bio/pharma sector.

ABPI has asked for a temporary ban to be put in place on drug exports by wholesalers to protect the National Health Service (NHS) from potential shortages in a ‘no-deal’ Brexit scenario.

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 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 Regulatory Affairs Professional Society (RAPS) has unveiled the details of its inaugural European regulatory conference, RAPS Regulatory Conference-Europe 2019.

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.