Drugs
CDER’s Office of Prescription Drug Promotion (OPDP) is proposing to conduct research to determine how physician perceptions are influenced by drug marketing, specifically with variations in information context (presence of graphical elements and information delivery vehicle— medical journal abstract or sales aid), methodologic rigor of the underlying clinical study
Drugs
FDA has approved a Celgene NDA for Otezla (apremilast) 30 mg twice daily for treating adult patients with oral ulcers associated with Behcet’s Disease. The oral, selective inhibitor of phosphodiesterase 4 was approved based on efficacy and safety results from the Phase 3 RELIEF study evaluating the drug in
Drugs
FDA has released a final guidance on “Submitting Next Generation Sequencing Data to the Division of Antiviral Products —Technical Specifications Document.” The document provides FDA’s current thinking on submitting next generation nucleotide sequence analysis procedures and data in support of resistance assessments for developing antiviral drug products. “The Division
Drugs
FDA has announced a 10/31 public meeting on “ICH Global Meeting on E8 Guideline on General Considerations for Clinical Trials.” The meeting is intended to discuss a planned revision to the E8 Guideline to provide updated guidance to address the increasing diversity of clinical trial designs and data sources
Drugs
Amarin Pharma says it will respond within weeks to a citizen petition asking FDA to make an exception to the statutory requirements for synthetic omega-3. Amarin says its response will explain that a product with synthetic eicosapentaenoic acid cannot be legally marketed as a dietary supplement because such marketing
Drugs
Researchers from several academic medical centers say that while the number of reports of pregnancies, abortions, and fetal defects among women taking isotretinoin has decreased since peaking around the 2006 start of the iPLEDGE program, persistent reporting of pregnancy-related events in the last decade warrants investigation into the efficacy
Drugs
Through a risk-based quality management system, FDA can receive data that are reliable, interpretable, and traceable, and thus may be able to act on a drug application before the user fee deadline. And acting on an application sooner can result in less expense for the sponsor. That’s the
Drugs
FDA has accepted Allergan’s NDA for Bimatoprost sustained-release for use in patients with open-angle glaucoma or ocular hypertension. The company says that if Bimatoprost SR is approved, it would be the first-in-class sustained-release, biodegradable implant for reducing intraocular pressure in patients with open-angle
Drugs
The CDER Office of Generic Drugs (OGD) FY 2018 GDUFA Science and Research Report shows that during FY 2018, the first year of GDUFA 2, the OGD Office of Research and Standards awarded 13 new research contracts and 11 grants for innovative research projects on generics. The report says that
Drugs
Novartis says it has reserved about $700 million to settle U.S. government allegations that it illegally enticed physicians to prescribe its drugs. A whistleblower lawsuit has accused the company of paying thousands of doctors with speaking fees, fishing trips and outings at Hooters restaurants to boost sales of hypertension
Drugs
FDA has accepted for review a Horizon Therapeutics NDA for Procysbi (cysteamine bitartrate) delayed-release oral granules in packets, a new dosage form intended to provide another option for patients. Currently, Procysbi is approved in a delayed-release capsule form for treating patients with nephropathic cystinosis. If approved, the oral
Drugs
A Milwaukee Journal Sentinel investigative report says that of 21 biologic drugs approved by FDA, 62% (13 drugs) have received an agency Boxed Warning. In the majority of those cases, the Boxed Warning was added when new problems were identified after the drug went on the market. The lengthy report
Drugs
A Congressional Budget Office (CBO) analysis of S. 1895, the Lower Health Care Costs Act, sponsored by Sen. Lamar Alexander (R-TN), says that provisions in the measure would allow some generic or biosimilar drugs to enter the market earlier. The analysis says the bill has several provisions that would
Drugs
FDA has issued a draft guidance, Advanced Prostate Cancer: Developing Gonadotropin-Releasing Hormone Analogues, with the agency’s current recommendations for an overall development program to establish the effectiveness and safety of gonadotropin-releasing hormone analogues for treating advanced prostate cancer. The document says that new drug applications for the
Drugs
FDA has approved Merck’s Recarbrio (imipenem, cilastatin and relebactam), an antibacterial drug product to treat adults with complicated urinary tract infections (cUTI) and complicated intra-abdominal infections (cIAI). “It is important that the use of Recarbrio be reserved for situations when there are limited or no alternative antibacterial drugs
Drugs
Pharmaceutical Research and Manufacturers of America (PhRMA) says FDA should reaffirm and reinforce the statutory distinction between drugs and dietary supplements as established in the Dietary Supplement Health and Education Act of 1994 (DSHEA). Responding to an FDA request for comments on responsible innovation in dietary supplements, PhRMA says that
Drugs
A 1/28-2/5 FDA inspection at the Strides Pharma Science drug manufacturing facility in Puducherry, India, found significant violations of current good manufacturing practice regulations for finished pharmaceuticals. A 7/1 Warning Letter says specific violations were: * failing to establish an adequate quality control unit with the responsibility
Drugs
An FDA Center of Excellence in Regulatory Science and Innovation (CERSI) research study conducted with Yale University and the Mayo Clinic will use the Biofourmis BiovitalsHF mobile platform, starting with a study of patients with heart failure to monitor functional capacity and quality of life to see if greater emphasis
Drugs
FDA has posted a draft guidance as its seventh revision to “Providing Regulatory Submissions in Electronic Format — Certain Human Pharmaceutical Product Applications and Related Submissions Using the eCTD Specifications.” The document describes how sponsors and applicants must organize the content that they submit to the agency electronically for all submission
Drugs
An 8/17-9/7/18 FDA inspection at the Ecometics drug manufacturing facility in Norwalk, CT, found significant repeat violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. A just-released 4/16 Warning Letter says specific violations were: * failing to establish and follow adequate written procedures
Drugs
Rep. Mike Kelly (R-PA), a diabetic and member of the Congressional Diabetes Caucus, is asking FDA for information on issues that may have contributed to it not listing insulin as a peptide drug product eligible for generic production in ANDA guidance issued 10/2017. In a 7/16 letter
Drugs
Amgen says an FDA draft guidance on adjusting for covariates in randomized clinical trials for drugs and biologics with continuous outcomes is easy to read and concise. In a comment letter, the company says it would be useful to add recommendations on how stratification variables should be handled, more detailed