Drugs
A 6/6-6/8/16 FDA inspection at Suzhou Pharmaceutical Technology, Suzhou, China, found significant deviations from current good manufacturing practice regulations for active pharmaceutical ingredients (APIs), according to a 1/6 Warning Letter. Specific deviations cited in the letter include: * failing to transfer all quality or regulatory information
Drugs
The Supreme Court has granted Sandoz’ petition and Amgen’s cross-petition that it hear their appeal of a federal appeals court decision in Amgen v. Sandoz. The acting solicitor general had urged the high court to hear the case, saying that the Federal Circuit Court of Appeals erred in
Drugs
FDA has posted a new draft guidance on “Medical Product Communications That Are Consistent With the FDA-Required Labeling — Questions and Answers” dealing with how the agency evaluates firms’ medical product communications that present information that is not contained in, but may still be consistent with, the FDA-required labeling.
Drugs
FDA has published a draft guidance, Considerations for Demonstrating Interchangeability with a Reference Product, to help sponsors show that a proposed therapeutic protein product is interchangeable with a reference product for the purpose of submitting a marketing application or supplement under the Biologics Price Competition and Innovation Act (BPCIA). The
Drugs
BIOLOGICS Vaccine Advisory Committee to Review Influenza Vaccines Federal Register Notice: FDA has announced a 3/9 Vaccines and Related Biological Products Advisory Committee meeting. Panel members will meet in open session to discuss and make recommendations on the selection of strains to be included in the influenza virus vaccines
Drugs
FDA has posted a draft guidance on “Referencing Approved Drug Products in ANDA Submissions” that provides information to potential applicants on how to identify a reference listed drug (RLD), reference standard, and the basis of submission in ANDA submissions. A reference standard selected by FDA is the specific drug product
Drugs
The International Council for Harmonization (ICH) is looking to “renovate” its guidelines on good clinical practice. A new white paper from the group entitled “ICH Reflection on ‘GCP Renovation’: Modernization of ICH E8 and Subsequent Renovation of ICH E6” outlines an approach to update guidelines on clinical trial design, planning,
Drugs
FDA has issued two guidances on human drug compounding. The first, Repackaging of Certain Human Drug Products by State-Licensed Pharmacies and Outsourcing Facilities, has been issued in final form to describe the conditions under which FDA does not intend to take action for certain violations of the Federal Food,
Drugs
FDA says that consumers should not purchase or use PNC-27, a product promoted online as a treatment or cure for cancer. An agency drug safety communication says that an agency laboratory discovered the bacteria Variovorax paradoxus in a PNC-27 solution sample for inhalation. The notice says FDA has
Drugs
FDA has issued a guidance, Nonproprietary Naming of Biological Products, calling for biological products licensed under the Public Health Service Act to have a nonproprietary name that includes an FDA-designated four-letter suffix. The document says that under this convention, the “nonproprietary name for each originator biological product, related
Drugs
FDA has posted a draft guidance on “180-Day Exclusivity: Questions and Answers” that addresses questions that have been raised about Food, Drug, and Cosmetic Act provisions related to generic drug exclusivity. The agency believes such a guidance “would enhance transparency and facilitate the development, approval, and timely marketing of
Drugs
FDA has released a draft guidance on “Multiple Endpoints in Clinical Trials” that discusses the problems posed by multiple endpoints in the analysis and interpretation of drug/biologic study results and how these problems can be managed in clinical trials. Most drug clinical trials contain multiple endpoints to assess the
Drugs
Kremers Urban Pharmaceuticals says FDA has ignored two Freedom of Information Act (FOIA) requests for information on its ANDA for extended-release methylphenidate tablets for which the agency says it intends to withdraw approval. The company filed suit in DC district court, saying it received an agency 10/17/16
Drugs
FDA has granted RedHill Biopharma a Qualified Infectious Disease Product (QIDP) designation for RHB-104 and its use in treating Nontuberculous Mycobacteria (NTM) infections. The QIDP designation was granted under the Generating Antibiotic Incentives Now (GAIN) Act, which is intended to encourage development of new antibiotic drugs for treating serious
Drugs
Attorneys Benjamin Zegarelli and Eli Greenspan (Mintz Levin) say that an FDA 1/9 final rule amending the definition of “intended use” for drugs and medical devices, which could be subject to congressional rollback, is something that industry might prefer to keep on the books. Writing in an online blog
Drugs
In a three-year progress report on its regulation of drug compounding under the Drug Quality and Security Act of 2013, FDA says its oversight efforts have had a significant public health impact. The report lists these accomplishments: * significantly increased agency inspections of facilities where drugs are being compounded with
Drugs
A QuintilesIMS Institute report on “Lifetime Trends in Biopharmaceutical Innovation” says that from a numerical perspective and anticipating the progress of drug candidates currently in the research and development pipeline, the state of biopharmaceutical innovation is robust. The report says that a total of 667 innovative biopharmaceuticals launched in the
Drugs
CDER has posted a list of 101 new and revised draft guidances in 16 categories it plans to publish in FY 2017. Categories, with the number of planned guidances, are advertising (1), biopharmaceutics (3), biosimilarity (2), clinical/antimicrobial (1), clinical/medical (11), clinical pharmacology (8), clinical/statistical (3), drug safety
Drugs
FDA has accepted Mylan’s BLA for a proposed biosimilar trastuzumab (Genentech’s Herceptin), indicated to treat certain HER2-positive breast cancers. The company says that the anticipated FDA goal date under the Biosimilar User Fee Act is 9/3.
Drugs
A Tufts Center for the Study of Drug Development survey says that poor doctor and nurse engagement is driving low patient recruitment for clinical trials. Survey results reported (purchase or subscription required) in the center’s Impact Report indicate that while doctors and nurses have a high familiarity and comfort
Drugs
FDA has accepted for priority review a Merck supplemental BLA for Keytruda (pembrolizumab), the company’s anti-PD-1 therapy, plus chemotherapy (pemetrexed plus carboplatin) for the first-line treatment of patients with metastatic or advanced non-squamous non-small cell lung cancer (NSCLC) regardless of PD-L1 expression and
Drugs
Galena Biopharma says it faces greater risks as it learns more about a 12/16/15 subpoena from the U.S. Attorney in New Jersey for records relating to the company’s marketing and promotional practices for Abstral (fentanyl), which it sold in the fourth quarter of that year. The