Internationalpharmaceuticalregulatorymonitor

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September 2018

Vol. 46
No. 9

Headlines

FDA Grants First Approvals Via the Competitive Generic Therapy Pathway

The FDA approved drug products under the Competitive Generic Therapy (CGT) designation for the first time, granting approval to several strengths of Apotex’s potassium chloride oral solution. Read More

EMA to Further Scale Back Activities as Brexit Creates Staff Upheaval

The European Medicines Agency said it needs to scale back or suspend more activities, blaming Brexit for staff reductions that are disrupting its ability to function. Read More

TGA Calls for Comments on Boxed Warning Requirements

Australia’s Therapeutic Goods Administration issued draft guidance for sponsors on prescription drug boxed warnings recommending the use of formats designed to instantly grab readers’ attention. Read More

MHRA: Brexit Won’t Change EU Drug Market Access

UK drug manufacturers will retain access to EU markets during the Brexit implementation period, the MHRA said, noting EU authorities will continue to recognize the UK’s manufacturing and distribution licenses as well as inspections. Read More

FDA: Guidance on Quality Chewables

The FDA released final guidance on quality attributes sponsors should consider for chewable tablets, suggesting they should be easy to chew, have a “bearable” taste and disintegrate easily. Read More

FDA Finalizes Dissolution Testing Guidance for Solid Oral Dosage Forms

The FDA issued final guidance on dissolution testing for immediate-release solid oral dosage form drugs containing high solubility substances. Read More

FDA Issues New Manual for Prioritizing Site Inspections

The FDA released a new manual of policies and procedures (MAPP) outlining how it prioritizes manufacturing facilities for routine CGMP surveillance inspections. Read More

FDA Issues Guidance on Postapproval Manufacturing Changes for Synthetics

The FDA issued guidance on how sponsors of synthetic drugs should approach post-approval manufacturing process changes — listing examples of low, medium and high risk changes. Read More

Canadian Manufacturer Warned for Adulterated APIs

The FDA warned Montreal, Quebec-based drugmaker Les Produits Chimiques that serious quality unit failures caused its APIs to be adulterated. Read More

FDA Releases Final Guidance on Drugs for Hay Fever, Non-Allergic Rhinitis

The FDA issued new guidance for sponsors of drugs designed to treat hay fever as well as other cold-like symptoms that aren’t caused by allergies. In a pair of final guidances, the agency urges drug sponsors to focus on real-world settings when trying to determine doses. Read More

FDA May Hit Record for Generic Approvals

The FDA is on track to top its fiscal year 2017 record for generic approvals despite receiving fewer ANDA submissions, according to the agency’s latest generic drug activities report. Read More

Stakeholders Seek Clarification of FDA’s Adolescent Oncology Patient Guidance

The FDA’s draft guidance on inclusion of adolescents in adult oncology clinical trials should clarify how the agency’s thinking aligns with international regulations, stakeholders said in comments on the June 1 draft. Read More

Drugmakers Seek More Details on LPAD Pathway Draft Guidance

Merck and GlaxoSmithKline called for more information from the FDA in comments on the agency’s draft guidance for sponsors using the limited population pathway for antibacterial and antifungal drugs (LPAD). Read More

FDA Finalizes Guidance on Microdose Radiopharmaceutical Diagnostic Drugs

Sponsors conducting nonclinical radiopharmaceutical diagnostic drug trials can seek waivers for specific nonclinical pharmacology or toxicology studies, according to final guidance from the FDA. Read More

FDA Suggests Endpoints for Medicine-Assisted Opioid Treatments

Drug sponsors may not have to prove that a proposed medicine-assisted therapy helps addicts completely kick opioids but they will have to detail how well it helps cut dependence to win FDA approval, the agency says in a new draft guidance. Read More

FDA Issues Final Guidance on PBPK Analyses

The FDA released final guidance for drug sponsors on the content and formatting of physiologically-based pharmacokinetic (PBPK) analyses, including an expanded section on formatting and a simplified section on software. Read More

Two Drugmakers Ask FDA to Lift Monotherapy Restrictions for MDD

Janssen and Takeda called for more flexibility in the FDA’s draft guidance for sponsors of drugs that treat major depressive disorder (MDD). Read More

FDA to Replace Guidance on Developing New Pain Drugs

FDA Commissioner Scott Gottlieb said the agency plans to scrap its existing guidance on developing new pain drugs and replace it with guidances designed to promote development of new opioid alternatives and improve benefit and risk assessments of new opioid drugs in the works. “Everything is on the table,” Gottlieb said in announcing the move aimed at driving innovation for fresh options to the potent, addictive pain meds. He noted the initiative will include at least four new guidances. Read More

FDA Revises MOU on Interstate Distribution of Compounded Drugs

FDA Commissioner Scott Gottlieb announced a revised agreement between the agency and states on interstate distribution of compounded drugs, responding to concerns that the existing distribution limits are too low. Read More

FDA Calls Out Korean Manufacturer Over Contamination Concerns

An FDA inspection of Korean sterile OTC drug manufacturer Hanlim Pharm in January turned up multiple failures to follow procedures for preventing product contamination. Read More

EU Task Force Outlines Priorities for Drug Shortage Prevention

A European Union task force released a two-year plan to prevent or deal with drug shortages in the region. Read More