Drugs
Three CDER staffers say that drugs and biologics approved by FDA that mention target product profiles (TPPs) are associated with more efficient regulatory review times, perhaps because of increased planning or because the TPP promotes well-organized regulatory dialog. Writing in CellPress, the three say that TPPs are used as
Drugs
FDA has concluded a 4/10-18 inspection at Aurobindo Pharma’s formulations manufacturing facility at Bachupally in Hyderabad, India that resulted in a six-item Form-483. “The observations are all on procedural improvements,” the company said. “None of them are related to data integrity.” A 10/17-10/
Drugs
Egalet Corp. has submitted a prior approval supplement for Oxaydo (oxycodone HCl, USP) tablets that seeks to market 10 mg and 15 mg dosage strengths for use in treating moderate to severe pain. The submission is based on a pharmacokinetic study demonstrating bioequivalence of Oxaydo to its reference drug, Roxicodone
Drugs
FDA has released the FDA-483 issued at the end of a 1/18-1/30 inspection at ZS Pharma, a Coppell, TX, active pharmaceutical ingredient (API) manufacturer. Specific violations noted on the form include: * process validation procedures do not ensure the integrity of process validation, and the quality unit
Drugs
CDER has released a list of 103 new and revised draft guidances in 16 categories it plans to issue this calendar year. The categories and number of guidances included are: Advertising (1), Biopharmaceutics (3), Biosimilarity (2), Clinical/Antimicrobial (1), Clinical/Medical (12), Clinical Pharmacology (8), Clinical/Statistical (3), Drug Safety
Drugs
A part owner of the New England Compounding Center (NECC) is asking a Massachusetts federal judge to dismiss the only charge against him — fraud on FDA — since the agency has admitted that the law differentiating compounding firms from drug manufacturers was not clear. Gregory Conigliaro is arguing that charging someone
Drugs
The Coalition for Clinical Trial Awareness (CCTA) says Congress should include in the PDUFA reauthorization process “an effort to address a pressing public health challenge: lack of public awareness of the benefits of clinical trials leading to under-enrollment.” The request is in a 4/11 letter to leadership of
Drugs
FDA has denied a 12/21/16 petition from Metabolic Therapy, Inc., asking that the agency amend the over-the-counter monograph for external analgesic drug products to indicate that melatonin and hexaphosphate (IP6) are safe and effective for external analgesic drug products. The denial letter says that the information
Drugs
FDA has denied a 5/30/14 Center for Responsible Science petition asking that the agency amend its informed consent regulations to require specific standard warnings in informed consent documents for every phase of clinical trials. The denial letter says the petition asked for three specific standard warnings. “We note
Drugs
Today FDA posted its latest batch of Warning Letters that contained one medical product letter. It can be accessed by clicking on the link below. Targeted Medical Pharma Los Angeles, CA (3/29): FDA inspected the firm’s clinical site 6/2016 as part of its Bioresearch Monitoring Program and
Drugs
The Biotechnology Innovation Organization (BIO) says that FDA’s Combination Product Policy Council should develop recommendations for implementation of provisions introduced in the 21st Century Cures Act, particularly recommendations to account for prior findings of safety and effectiveness or substantial equivalence for an approved constituent part. The organization also asks
Drugs
AMAG Pharmaceuticals has submitted a supplemental NDA for Makena (hydroxyprogesterone caproate injection) to allow a subcutaneous auto-injector to deliver the drug. Currently, Makena is approved as an intramuscular injection, indicated to reduce the risk of preterm birth in women who are pregnant with one baby and who spontaneously delivered
Drugs
FDA has denied a CytoDyn request for an orphan drug designation (ODD) for PRO 140 because the therapy appears to have the potential to treat more than just the subset of multi-drug resistant HIV patients for which the designation was requested. CytoDyn is currently conducting a pivotal Phase 2b/
Drugs
FDA has scheduled a 5/24 Oncologic Drugs Advisory Committee meeting to review a Puma Biotechnology NDA for neratinib, an investigational therapy for the extended adjuvant treatment for early stage HER2-positive breast cancer in patients previously treated with a trastuzumab containing regimen. The submission is based on results from
Drugs
FDA has released a Form-483 from a 2/7-17 inspection at Abbott’s St. Jude Medical manufacturing facility in Sylmar, CA, that found Quality System Regulation violations related to battery problems associated with the Fortify, Unity, and Assura (including Quadra) implantable cardioverter defibrillators and cardiac resynchronization therapy defibrillators
Drugs
OncoMed Pharmaceuticals says results from a Phase 2 trial (PINNACLE) evaluating tarextumab failed to meet its primary endpoint (progression free survival) or secondary endpoint (overall survival). The randomized, 145-patient trial analyzed tarextumab (anti-Notch2/3, OMP-59R5) in combination with etoposide plus either cisplatin or carboplatin chemotherapy in previously
Drugs
FDA has approved Genentech’s Lucentis (ranibizumab injection) 0.3 mg for the monthly treatment of all forms of diabetic retinopathy. Diabetic retinopathy is the leading cause of blindness among adults aged 20 to 74 and affects nearly 7.7 million people in the U.S. In 2015, Lucentis was
Drugs
Rigel Pharmaceuticals has submitted an NDA for fostamatinib in patients with chronic and persistent immune thrombocytopenia (ITP). The submission is supported by data from a Phase 3 clinical program for fostamatinib in ITP, comprising three studies — two randomized placebo-controlled studies (Studies 047 and 048) and an open-label extension
Drugs
In a move to avoid layoff notices sent to FDA staff working under the agency’s user fee programs, Senate and House health committee leaders have released a bipartisan discussion draft of legislation reauthorizing the user fee agreements for the next five years. The measure reflects the recommendations sent by
Drugs
Standard Homeopathic has recalled all lots of Hyland’s Baby Teething Tablets and Hyland’s Baby Nighttime Teething Tablets sold in retail stores. FDA has concluded that the products “have been found to contain inconsistent amounts of belladonna alkaloids that may differ from the calculated amount on the products’ labels,
Drugs
Eli Lilly and Incyte say they disagree with an FDA complete response letter requesting additional data for their NDA for baricitinib, a once-daily oral medication for treating moderate-to-severe rheumatoid arthritis. The letter indicated that additional clinical data are needed to further characterize safety concerns across treatment arms,
Drugs
An Epstein Becker & Green client alert predicts an “imminent confirmation” of Scott Gottlieb to be the next FDA commissioner, which should be a win for industry based on his support of “flexible systemic approaches to shorten review timelines and bring more products to market.” Gottleib’s stance fares well