Drugs
CDER has issued a Manual on Policies and Procedures (MAPP), Development of a Single, Shared System (SSS) Risk Evaluation and Mitigation Strategy (REMS) or a Separate REMS with Elements to Assure Safe Use: Responsibilities and Procedures, outlining policy, responsibilities, and procedures to be used in CDER for two types of
Drugs
A 2/2-2/25 FDA inspection at the Shilpa Medicare Limited drug production facility in Telangana, India, found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/9 Warning Letter says specific violations were: * failing to thoroughly investigate any unexplained discrepancy or failure of
Drugs
FDA has published a guidance, Referencing Approved Drug Products in ANDA Submissions, providing information to potential applicants on how to identify a reference-listed drug (RLD), a reference standard, and the basis of submission in an ANDA. The document says a variety of factors has led to confusion among stakeholders
Drugs
Following the advice from an independent data and safety monitoring board, the National Institutes of Health (NIH) says no additional subjects will be enrolled in a clinical trial evaluating a Lilly investigational monoclonal antibody in hospitalized patients with Covid-19. The board made its recommendation based on a low likelihood
Drugs
The Washington, DC District Court has ruled that a recent FDA decision to remove a decades-old compliance policy affecting unapproved homeopathic drugs can be challenged in court. In Medinatura v. FDA, homeopathic product marketer MediNatura challenged the agency’s withdrawal of Compliance Policy Guide 7132.15, Section 400.400,
Drugs
A 2/4-3/13 FDA inspection at the KVK-Tech drug manufacturing facility in Newtown, PA, identified significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A 10/8 Warning Letter says specific violations were: * failing to establish and follow adequate written procedures for cleaning and
Drugs
Federal Register notice: FDA has announced a 12/15 Cardiovascular and Renal Drugs Advisory Committee meeting. Panel members are scheduled to discuss a Novartis supplemental NDA for the angiotensin receptor-neprilysin inhibitor Entresto (sacubitril and valsartan) tablets for the proposed indication of heart failure with preserved ejection fraction. To view
Drugs
FDA has awarded a multi-year grant to the Critical Path Institute (C-Path) to advance standards and methodologies designed to generate real-world evidence from real-world drug data through a neonatal pilot project by the International Neonatal Consortium (INC). C-Path says the grant will support the collection
Drugs
Janssen Pharmaceutical Companies has submitted a supplemental NDA for a new indication to expand the use of Xarelto (rivaroxaban) in patients with peripheral artery disease (PAD). “If approved, this new indication for the Xarelto vascular dose (2.5 mg twice daily plus aspirin 75-100 mg once daily) would include
Drugs
Federal Register notice: FDA has made available a final standard memorandum of understanding (MOU) entitled “Memorandum of Understanding Addressing Certain Distributions of Compounded Human Drug Products Between the [insert State Board of Pharmacy or Other Appropriate State Agency] and the U.S. Food and Drug Administration.” The MOU describes the
Drugs
FDA has accepted for review a Santen NDA for cyclosporine topical ophthalmic emulsion, 0.1% for treating severe vernal keratoconjunctivitis (VKC) in patients aged 4-18 years. VKC is a rare and recurrent allergic eye condition, most common in children and adolescents, that causes severe inflammation on the eye’s
Drugs
FDA has lifted a clinical hold against AstraZeneca and the University of Oxford to resume clinical trials of their coronavirus vaccine, AZD1222. The hold was imposed in September after Oxford had said a patient’s neurological problem was detected, but it was likely not related to the vaccine. Clinical trials
Drugs
The Western Virginia District Court has sentenced former Indivior CEO Shaun Thaxter to six months in federal prison after he pleaded guilty for his role in causing the introduction into interstate commerce misbranded shipments of the opioid drug Suboxone Film (buprenorphine). He was also ordered to pay a fine of
Drugs
FDA has sent For Our Vets (Mesa, AZ) a Warning Letter after reviewing its Web site and social media sites and determined that it offers cannabinoid (CBD) products for sale that are intended to mitigate, prevent, treat, diagnose, or cure Covid-19, making them unapproved drugs. FDA said it was
Drugs
New Delhi-based Aurobindo Pharma says that its U.S subsidiary AuroLife Pharma has received a Warning Letter based on an inspection at its oral solid manufacturing facility in Dayton, NJ. The company reported in June that it received a Form 483 citing nine GMP observations. The agency notified the
Drugs
The CDER Office of Generic Drugs has awarded a two-year $1.1 million contract to EpiVax and CUBRC to continue research performed during a previous two-year collaboration. EpiVax says that in the previous contract period it demonstrated the value of in silico tools and in vitro validation methods
Drugs
FDA has announced an additional three-year delay in enforcement of the requirement for wholesale distributors to verify saleable returned product as required under the Federal Food, Drug, and Cosmetic Act. A 2019 compliance policy said enforcement of the requirement would be delayed until 11/27/20. The agency has
Drugs
FDA has made available a final guidance on enforcing Drug Supply Chain Security Act (DSCSA) requirements for wholesale distributor verification of saleable returned products and dispenser verification of the product identifier for suspect and illegitimate products. The guidance, Wholesale Distributor Verification Requirement for Saleable Returned Drug Product and Dispenser Verification
Drugs
FDA has approved a Gilead Sciences NDA for Veklury (remdesivir), indicated for treating patients with Covid-19 that requires hospitalization. Remdesivir is the first treatment approved for treating Covid-19, according to the agency, and it previously was available in the U.S. under an emergency use authorization for treating
Drugs
FDA has approved a Leo Pharma supplemental NDA for updated prescribing information for Enstilar (calcipotriene and betamethasone dipropionate) Foam to include data on long-term use in adults with plaque psoriasis. The corticosteroid is approved for the topical treatment of plaque psoriasis in patients 12 years and older. The submission
Drugs
FDA has posted its latest quarterly report (April-June) of potential signals of serious risks/new safety information identified by the FDA Adverse Event Reporting System. The report lists 24 signals. FDA says it has determined that no action is necessary for four of the signals, while it continues to
Drugs
University researchers in the U.S. and Turkey say that, on average, three additional months of FDA regulatory review delay result in one fewer drug in development in that drug category. Writing in Health Economics the researchers say, “Our results suggest that the length of the regulatory review delay matters