Regulatory Oversight

A statement from FDA Commissioner Scott Gottlieb and Deputy Commissioner Anna Abram detailed FDA’s new plan to advance plant and animal biotechnology innovation.

Mock inspections-if conducted properly-can prepare a pharma company for the day FDA knocks on the door.

A federal court judge ordered Keystone Laboratories, Inc. of Memphis, Tennessee to stop selling over-the-counter drug products.

The agency, in partnership with international regulatory and law enforcement agencies, cracked down on 465 websites marketing illegal opioids and other drugs claiming to treat conditions such as cancer and HIV.

Takhzyro (lanadelumab) is the first monoclonal antibody therapy approved for the prevention of recurrent attacks of hereditary angioedema (HAE) in patients aged 12 years and older.

Promise Pharmacy recalls one lot of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% sterile, 3mL vials due to particulates in the solution.

The recommended drugs include one biosimilar, two orphan medicines, and three extensions of therapeutic indication.

This article explores major aspects for United States biotech companies to consider when creating a compliant post-Brexit strategy.

To achieve a more dynamic marketplace, FDA is issuingguidance documents and targeted advisories to support R&D on complex generics and combination products.

The contract development and manufacturing organization released its first serialized products to Europe from its facilities in Lisbon, Portugal and Stockholm, Sweden.

The agency is developing technology- and disease-specific regulatory frameworks for innovations that may not have previously had a clear development pathway.

The guidance describes the agency's recommendations on how to group patients with different molecular alterations and approaches for evaluating the benefits and risks of targeted therapies where some molecular alterations may occur at low frequencies.

The new guidance, Rare Diseases: 2 Early Drug Development and the Role of Pre-IND Meetings Guidance for Industry, discusses the planning of pre-IND meetings with FDA and sponsors.

Audits by independent experts promise to ease the burden that customer audits can have on suppliers, while ensuring drug manufacturers that ingredients meet strict cGMP standards.

The Medicines and Healthcare products Regulatory Agency (MHRA) has opened a consultation to seek views on how legislations and procedures of the agency may need to be modified should there be a ‘no-deal’ Brexit scenario.

Experts blame the recalls, not on cGMP failures, but on inadequate risk assessment of processes that can generate toxic impurities.

Susan Schniepp, executive vice-president of Post-Approval Pharma and Distinguished Fellow, Regulatory Compliance Associates, takes a look at the regulations around data integrity and how they relate to the concept of quality culture.

A European task force outlines its upcoming efforts to combat drug shortages.

Experts weigh in on up-to-date analytical procedures for the lot release testing of small-molecule pharmaceuticals.

As Europe and the United Kingdom are facing the ever-expanding shadow of Brexit, a keynote session taking place at CPhI Worldwide in Madrid will look to assess the wider implications of the UK’s exit from the European Union on the Pharma sector.

The agency sent a warning letter to the Indian company after an inspection found CGMP violations that included a lack of written procedures and analytical testing.

While food, shelter, and clothing are the primal essentials for life, hope-as embodied by modern medicine-has now become part of that human expectation.

CDER director plans to start implementation of new review practices by the end of 2018.

The sterile-manufacturing contract development manufacturing organization is approved by FDA for viral vector manufacturing fill/finish processing at its biologics facility in Scotland, UK.

The European Medicines Agency revised the number of centrally authorized medicines for which there are concerns over Brexit-related supply disruptions.

The agency announced that differences in strength expression on product labels of compounders and conventional manufacturers may lead to dosing errors.

The agency has entered into an agreement with the National Academies of Science, Engineering & Medicine and has expanded agreements with the University of Maryland and Johns Hopkins University Centers for Regulatory Science and Innovation to conduct research on the compounding of drugs.

The European Medicines Agency’s detection of a second nitrosamine in a sartan API is driving a deeper dive into tetrazole chemistry; root-cause investigations will now include not only valsartan and losartan, but candesartan, irbesartan, and olmesartan.

The agreement now includes 15 European Union (EU) member states.

FDA sent a warning letter to Lernapharm (Loris) Inc. detailing the company’s lack of procedures to prevent microbiological contamination.