The US Food and Drug Administration (FDA) on Monday issued a draft guidance on clinical pharmacology considerations for sponsors interested in developing antibody-drug conjugates (ADC). There is currently no guidance addressing these drugs, said the agency.   The guidance provides recommendations for ADCs, which are defined as an antibody or antibody fragment conjugated to at least one payload molecule via a chemical linker for treating cancer. They are regulated as ...

Developing therapies for rare diseases involves complex incentives, unique requirements, and often extensive patient engagement. The authors of RAPS’ Orphan Drug Development for Rare Diseases , Sundar Ramanan, PhD, MBA, and Sunny Kamlesh Dave, MPharm, recently took time to discuss with RAPS Senior Editor Gloria Hall the importance of orphan drugs, the peculiarities and challenges of obtaining an orphan drug designation (ODD), and what is covered in the book. During a “m...

The US Food and Drug Administration’s (FDA) Center for Drug Evaluation and Research (CDER) approved 50 new drug therapies in 2021. While the figure is a slight decrease from 2020 , more drugs were designated as first-in-class and used the accelerated approval pathway than in previous years.   The approvals reported by CDER do not include biologics license applications (BLAs) approved by FDA’s Center for Biologics Evaluation and Research (CBER). In 2021, CBER approved...

This article discusses advertising on streaming media and what regulatory reviewers need to take into consideration when reviewing online videos.   Introduction Television. One word, many meanings – it could be the wide-screen home TV, the latest Hulu-exclusive series we binge-watch on an iPad, or the 5-minute Snapchat original series that releases a new episode every week. There is no shortage of places for consumers to view video content outside of a traditional ...

The US Food and Drug Administration (FDA) on Thursday issued a draft guidance to help manufacturers set up inspection testing programs to ensure that their injectable drugs are free of visible particles.   The 18-page draft guidance "addresses the development and implementation of a holistic, risk-based approach to visible particulate control that incorporates product development, manufacturing controls, visual inpsection techniques, particulate identification, inves...

Pharmaceutical industry trade groups and medical device groups objected to the US Food and Drug Administration’s (FDA) plans to reclassify some products, including imaging agents, currently regulated as drugs to devices, in implementing a recent court decision. The Association for Accessible Medicines (AAM) says that the agency’s implementation of the order is hasty and has no legal merit, while the Advanced Medical Technology Association (ADVAMED) pointed out that compani...

The US Food and Drug Administration’s (FDA) Office of Generic Drugs (OGD) has announced its science and research priorities for fiscal year (FY) 2022 to spur the development of complex generic drugs. The priorities were prompted by public feedback the agency received at a public workshop earlier this year.   The agency also announced the availability of fellowships and funding for research activities that are aligned with these priorities.   The workshop was held i...

This article provides a summary of drugs and biologic products that have recently become available for the pediatric population in the United States. It highlights prescription products for attention deficit hyperactivity disorder (ADHD), psoriasis, active polyarticular juvenile idiopathic arthritis (pJIA), active psoriatic arthritis, Ebola virus treatment, spinal muscular atrophy, and bladder dysfunction that became available in 2019, 2020, and 2021 after completion of pe...

  A new draft guidance from the US Food and Drug Administration (FDA) gives cell and gene therapy developers a detailed framework for the conduct of umbrella trials, offering the potential for enhanced speed and efficiency in early-stage clinical trials.   In the umbrella trials envisioned under the draft guidance, two or more versions of a cellular or gene therapy product would be studied for one specific disease using just one trial design, shared infrastructure, a...

The US Food and Drug Administration (FDA) on Wednesday issued a draft guidance to help manufacturers control microbiological contamination of their non-sterile drugs (NSDs). The guidance stems from FDA’s concerns over a high number of adverse events and recalls associated with contaminated products.   The agency reports receiving 197 adverse event reports from microbiological or fungal contamination of non-sterile products between 2014 and 2017. Of these, 32 were deeme...

Slipshod testing of two over-the-counter (OTC) analgesics along with improper marketing of one led the US Food and Drug Administration (FDA) to issue three warning letters to manufacturers located outside the US. Additionally, the agency continued its crackdown on imported hand sanitizers.   The recipients of the warning letters, which were all issued in mid-September, include Laboratorio Pharma International in Tegucigalpa, Honduras, a manufacturer of antibiotics and ...

The US Food and Drug Administration’s Center for Drug Evaluation and Research (FDA’s CDER) on Monday issued a draft guidance that provides generic drug applicants with answers to commonly asked questions in the drug quality area. The new guidance is designed to provide an immediate response to such questions to reduce the number of controlled correspondence on identical topics.   The guidance, which is in a question-and-answer format, covers FDA’s policies on quality...