Regulatory Updates October 2020

Join us at weekly Journal Club meetings and connect with students, faculty and staff of Regulatory Science Program. Read the latest Regulatory Updates October 2020.

For general information on Education Initiatives, click here. Highlight posted on November 6, 2020


EMA Kicks off Rolling Review of Astra Zeneca COVID Vaccine Candidate

The European Medicines Agency (EMA) human medicines committee (CHMP) has begun a rolling review of the Astra Zeneca/Oxford vaccine candidate, which is based on an engineered chimpanzee adenovirus vector platform called ChAdOx1, because preliminary results from non-clinical and early clinical studies suggest the vaccine triggers the production of antibodies and T cells that target the virus.

FDA Gives Draft Adjuvant Trial Guidance for Renal Cell Carcinoma, Bladder Cancer

Two new draft guidance from the U.S. Food and Drug Administration (FDA) give investigators a roadmap for clinical trials of adjuvant drug or biologic therapy for two common cancers; bladder cancer, and renal cell carcinoma (RCC). “The FDA has actively encouraged a more uniform approach to developing clinical trials to evaluate adjuvant treatments for renal cell carcinoma and bladder cancer”, said Richard Pazdur, MD, director of the FDA Oncology Center of Excellence.

FDA Seeks Withdrawal of Makena, Generics from Market

The U.S. Food and Drug Administration (FDA) proposed to withdraw Amag Pharmaceuticals’ preterm birth drug Makena (hydroxyprogesterone caproate injection) and its generics from the market after a post-market study failed to demonstrate a statistically significant benefit over a placebo in reducing preterm delivery or neonatal morbidity and mortality.

FDA Announces All-Time Low Rates for FY2021 PRVs

The U.S. Food and Drug Administration (FDA) has announced historic low rates for fiscal year 2021 fees to use material threat medical countermeasure (MCM) priority review voucher (PRV) programs.

FDA Issues COVID-19 Vaccine EUA Guidance

The U.S. Food and Drug Administration (FDA) issued final guidance, which explains the statutory criteria for a COVID-19 vaccine emergency use authorization (EUA) and provides recommendations for the regulatory, chemistry, manufacturing and controls (CMC), and safety and effectiveness information, after disclosing some of its advice to vaccine makers in briefing documents for an upcoming advisory committee meeting.


Stem Cell Clinic Slapped with CBER Warning

A chiropractor who operates a stem cell clinic has received an untitled letter from the U.S. Food and Drug Administration (FDA) for marketing intrathecal and intravenous injection of human stem cell products to treat Parkinson’s disease and diabetes. The Center for Biologics Evaluation and Research (CBER) letter clarifies that lawful marketing of OHSTEMCELL products require that they have biologics licenses, which they do not.

Generic Drug-Makers Get Revised MAPP for Suitability Petitions

The Manual of Policies and Procedures (MAPP) published by the U.S. Food and Drug Administration (FDA) Office of Generic Drugs lays out how applicants can petition to submit an abbreviate new drug application (ANDA) when the generic drug differs from the reference listed drug (RLD) in dosage form or strength, or in its route of administration.

Voyager Takes a Hit after FDA Places Hold on Gene Therapy for Huntington’s Disease

U.S. Food and Drug Administration (FDA) placed a clinical hold on the Voyager Therapeutics Investigational New Drug (IND) application for VY-HTT01 for the treatment of Huntington’s disease until the resolution of specific chemistry, manufacturing and controls (CMC) concerns.

TGA Moves Astra Zeneca’s Vaccine on First Step toward Approval

The Australian Therapeutic Good Administration (TGA) has taken the first step toward provisional approval of the Astra Zeneca/ Oxford vaccine, ChAd0x1-S, against COVID-19. This first step means that Astra Zeneca can now apply for provisional registration in the Australian Register of Therapeutic Goods (ARTG). 


CDER Launches Quality Management Maturity Pilots for APIs and Finished Dosage Forms

The U.S. Food and Drug Administration (FDA) has launched two pilot programs related to manufacturing quality management. One pilot program will characterize quality management maturity (QMM) for finished dosage forms for domestic manufacturers of prescription and over-the-counter (OTC) drug products. The second pilot will look at QMM for active pharmaceutical ingredients (APIs), including drug substance intermediates, from foreign manufacturers destined for use in FDA-regulated prescription and OTC products.

IMDRF Proposes Update on Post Marketing Device Studies

The International Medical Device Regulators Forum (IMDRF) has issued a proposed update to its guidance on post market clinical follow-up (PMCF) studies for medical devices, with advice on the design, implementation, and appropriate use of these studies. The guidance does not apply to in vitro diagnostic devices. The proposal is open for consultation until 11 December 2020.

CHMP: Test All Metformin for Nitrosamines before Release

The European Medicines Agency (EMA) Committee for Medicinal Products for Human Use (CHMP) said that, medicines containing the diabetes medication metformin must be tested for the presence of nitrosamines before being released into the European market. Nitrosamines have been found at elevated levels in the antacid ranitidine, in certain anti-hypertensive medications and tuberculosis drugs, and in extended release metformin. The substance occurs naturally in minute amounts, but elevated levels may be carcinogenic.

TGA Gives Pfizer COVID Vaccine Provisional Determination

The COVID-19 vaccine candidate, BNT12b2, being developed by Pfizer, has received provisional determination from the Australia Therapeutic Goods Administration (TGA). TGA’s provisional regulatory pathway gives sponsors an accelerated, but still “formal and transparent,” mechanism to speed up registration of medicines and vaccines the agency deems promising, using more preliminary clinical data than would be required for a full approval for inclusion in the Australian Register of Therapeutic Goods (ARTG).

Philippine FDA Posts COVID Trial Guidance

The Philippine Food and Drug Administration (FDA) aims to process clinical trial requests for COVID-19 therapeutics in 30 days and vaccines in 40 days, compared to 60 days under the standard workflow, according to new guidance. The big difference is that the regulatory review stage will take 14 days, compared to 45 days under the standard process.


Remdesivir Receives FDA Approval for COVID-19

The antiviral remdesivir received approval from the U.S. Food and Drug Administration (FDA) on 22 October to treat older children and adults who are hospitalized with COVID-19. The approval of remdesivir was supported by the agency’s analysis of data from three randomized, controlled clinical trials that included patients hospitalized with mild-to-severe COVID-19.

FDA Authorizes Restart of the COVID-19 AZD1222 Vaccine U S  Phase III Trial

Clinical trials for the AstraZeneca/Oxford coronavirus vaccine, AZD1222, have resumed across the world with regulators in the U.S., U.K., Brazil and South Africa confirming that it was safe to do so. Based on this evaluation, the U.S. Food and Drug Administration (FDA) authorized the restart in the U.S. after reviewing all safety data from trials globally and concluded it was safe to resume the trial.

EMA Highlights Multiple Considerations When Developing Drugs for Older Adults

The European Medicines Agency (EMA) urged pharmaceutical manufacturers to consider the physical and cognitive abilities of patients age 65 years and older when developing products. Those considerations may impact everything from the dosage form to the package labeling. The document highlights patient acceptability – the ability and willingness to self-administer medication — as a key consideration for older patients.

FDA Grants Priority Review and EMA Accepts Regulatory Submission for Pfizer’s Abrocitinib

The U.S. Food and Drug Administration (FDA) accepted for filing and granted Priority Review designation to Pfizer’s New Drug Application (NDA) for abrocitinib (100mg and 200mg), for the treatment of moderate to severe atopic dermatitis (AD) in patients 12 years of age and older, as did the European Medicines Agency (EMA). The filings were based on results of a Phase 3 clinical trial, across which abrocitinib demonstrated superior improvements and safety profile.