Drugs
FDA has released a new plan to modernize dietary supplement regulation and oversight. It has been more than 25 years since Congress passed the Dietary Supplement Health and Education Act (DSHEA), and the regulated industry has exploded from 4,000 unique products to potentially more than 80,000 different products
Drugs
FDA’s Office of Criminal Investigations helped investigate a case where James Paul Adams (Cypress, TX), owner of One Source Healthcare Organization, agreed to pay the government $339,413 for allegedly accepting illegal kickback payments from OK Compounding. The government alleged OK Compounding paid substantial kickbacks to various third-party
Drugs
FDA has updated summary table forms (XXINSERT LINKXX) for ANDA submissions containing clinical endpoint studies. The previous version has been updated, and now includes two separate documents — one for submissions containing comparative clinical endpoint bioequivalence studies, and the other for submissions containing irritation/sensitization/adhesion studies (for transdermal and topical
Drugs
FDA has issued 12 Warning Letters and five online advisory letters to foreign and domestic companies that are “illegally” selling more than 58 products, which include dietary supplements, that are unapproved or misbranded drugs because they are claiming to treat Alzheimer’s disease and other serious health conditions. The products,
Drugs
FDA has approved a Perrigo ANDA for a generic copy of GlaxoSmithKline’s Zovirax Cream, 5% (acyclovir cream), indicated as an antiviral treatment for cold sores. Annual sales for acyclovir cream is about $92 million, according to Perrigo.
Drugs
Johnson & Johnson pharmaceutical group Janssen says it is taking the lead to begin including list price information in drug direct-to-consumer (DTC) TV ads. Later this quarter, the company says pricing disclosures will begin with its oral anti-coagulant Xarelto, and the advertising will include both the list
Drugs
FDA has issued a final guidance outlining circumstances when a company should issue a public warning about a voluntary recall, describing the general timeframe for companies to issue such a warning, discussing what information should be included in a public warning, and describing situations where FDA may take action to
Drugs
A new report on citizen petitions submitted to FDA to delay or prevent a drug/biosimilar approval finds that only one product was delayed approval due to such a filing, but the agency is concerned about the number of resources re-directed to meet statutory response timelines. In the report
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says it supports FDA’s efforts to update its 2005 final guidance on good review management principles and practices (GRMP) for NDAs and BLAs. “Due to the proposed updates and streamlining in the draft guidance,” the association says, “PhRMA strongly urges the agency
Drugs
CDER has issued a Manual of Policies and Procedures (MAPP) on the responsibilities and procedures for developing a single, shared system risk evaluation and mitigation strategy (REMS) or a separate REMS with elements to assure safe use. The MAPP does not include information on other agency actions, such as complete
Drugs
FDA has approved a Grifols PMA for the Procleix Babesia assay, a qualitative test for detecting ribosomal RNA from four Babesia species (B. microti, B. duncani, B. divergens, B. venatorum) in individual samples or up to 16 pooled lysed specimens from human donors, including donors of whole blood and blood
Drugs
Vanda Pharmaceuticals has filed a complaint against FDA in DC federal court seeking to remove a partial clinical hold the agency “illegally imposed prohibiting Vanda from studying a promising new drug in humans for more than 12 weeks without conducting unnecessary and unethical animal studies.” The affected drug is tradipitant,
Drugs
The International Conference on Harmonization (ICH) has issued a “reflection paper” outlining a strategic approach for developing and enhancing ICH guidelines to support harmonization of scientific and technical standards for generic drugs. As part of the approach, the paper outlines recommendations to develop a series of ICH guidelines on standards
Drugs
CDER director Janet Woodcock says agency efforts to modernize its drug regulatory program “will reach a crescendo in 2019 when we’ll be going into implementation. So we’ll begin to see a lot of changes, and I call on all of you for your help and assistance in making
Drugs
FDA has issued a final guidance entitled “Opioid Use Disorder (OUD): Developing Buprenorphine Depot Products for Treatment,” which outlines the agency’s current thinking about drug development and trial design issues for such products, such as modified-release formulations for injection or implantation. “When combined with the right treatments and
Drugs
FDA has released a draft guidance entitled: “Eosinophilic Esophagitis (EoE): Developing Drugs for Treatment” that assists sponsors with their clinical development of drugs/biologics for treating this condition. The document addresses FDA’s current recommendations for clinical trials for such drugs and the necessary attributes of patients for enrollment, efficacy
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says the International Council for Harmonization (ICH) document Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifestyle Management, could benefit from additional examples and clarity around the application of the specific tools and enablers introduced by the guidance. In just-released 12/15/
Drugs
Merck says the FDA Framework for FDA’s Real-World Evidence Program, which fulfills the 21st Century Cures Act requirement for the agency to establish a program to evaluate potential use of real-world evidence to help support approval of a new indication for a drug approved under section 505(
Drugs
The Biotechnology Innovation Organization (BIO) says an FDA draft guidance on early drug development for rare diseases and the role of pre-IND meetings “provides important information to drug developers regarding pre-IND meetings to support better the consistency, transparency, [and] efficiency of drug development, and the review of rare
Drugs
FDA has approved a Ablynx BLA for Cablivi (caplacizumab-yhdp) injection, the first therapy specifically indicated, in combination with plasma exchange and immunosuppressive therapy, for treating adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), a rare and life-threatening disorder that causes blood clotting. Patients with aTTP develop extensive blood
Drugs
FDA has issued a draft guidance, Principles of Premarket Pathways for Combination Products, to provide the agency’s current thinking on principles for premarket review of combination products, including how to determine which type of premarket submission is appropriate. “This guidance offers general, high-level information relevant to combination products,
Drugs
A federal court in western Pennsylvania has entered a consent decree against Ranier’s Rx Laboratory (doing business as Ranier’s Compounding Laboratory) in Jeanette, PA and pharmacist/owner Francis H. Ranier. The court action prohibits Ranier’s and its owner from, among other things, manufacturing, holding, or distributing human